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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03842163
Registration number
NCT03842163
Ethics application status
Date submitted
13/02/2019
Date registered
15/02/2019
Date last updated
12/02/2024
Titles & IDs
Public title
Prevalence and Characteristics of Transthyretin Amyloidosis in Patients With Left Ventricular Hypertrophy of Unknown Etiology
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Scientific title
PREVALENCE AND CHARACTERISTICS OF TRANSTHYRETIN AMYLOIDOSIS IN PATIENTS WITH LEFT VENTRICULAR HYPERTROPHY OF UNKNOWN ETIOLOGY TTRACK
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Secondary ID [1]
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TTRACK
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Secondary ID [2]
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B3461058
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Universal Trial Number (UTN)
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Trial acronym
TTRACK
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Neurological
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Other neurological disorders
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Metabolic and Endocrine
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Other metabolic disorders
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Cardiovascular
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Other cardiovascular diseases
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Metabolic and Endocrine
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0
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Metabolic disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Diagnosis / Prognosis - Diagnosis of TTR amyloidosis cardiomyopathy
Patients with LVH of unknown etiology -
Diagnosis / Prognosis: Diagnosis of TTR amyloidosis cardiomyopathy
Diagnosis of TTR amyloidosis cardiomyopathy with scintigraphy
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Intervention code [1]
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Diagnosis / Prognosis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Cardiac Fixation at the Radionuclide Bone Scintigraphy and/or Single Photon Emission Computed Tomography (SPECT): FAS1
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Assessment method [1]
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Percentage of participants with cardiac fixation on a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD or 99mTc-PYP or 999mTc-HMDP among participants with LVH from an undiagnosed etiology were reported in this outcome measure. Scintigraphy was defined at each bone site according to the standard grading: Grade 0 = absent cardiac uptake, Grade 1=mild uptake less than bone, Grade 2=moderate uptake equal to bone and Grade 3=high uptake greater than bone.
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Timepoint [1]
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During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [1]
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Percentage of Participants With Transthyretin Amyloid (ATTR): FAS 1
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Assessment method [1]
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Transthyretin amyloidosis is a slowly progressive condition characterized by the buildup of abnormal deposits of a protein called amyloid (amyloidosis) in the body's organs and tissues.
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Timepoint [1]
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During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [2]
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Percentage of Participants With ATTR or With Suspicion of Monoclonal Gammopathy of Undetermined Significance (MGUS) / Light Chain Amyloidosis (AL): FAS 1
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Assessment method [2]
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Transthyretin amyloidosis is a slowly progressive condition characterized by the buildup of abnormal deposits of a protein called amyloid (amyloidosis) in the body's organs and tissues.
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Timepoint [2]
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During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [3]
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Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): Full Analysis Set 2 (FAS 2)
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Assessment method [3]
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Percentage of participants with hereditary ATTRv were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with variant transthyretin was considered as ATTRv.
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Timepoint [3]
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During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [4]
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Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): Full Analysis Set 3 (FAS 3)
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Assessment method [4]
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Percentage of participants with hereditary ATTRv were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with variant transthyretin was considered as ATTRv.
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Timepoint [4]
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During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [5]
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Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): FAS 3.1
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Assessment method [5]
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Percentage of participants with hereditary ATTRv were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with variant transthyretin was considered as ATTRv.
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Timepoint [5]
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During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [6]
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Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): FAS 3.2
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Assessment method [6]
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Percentage of participants with hereditary ATTRv were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with variant transthyretin was considered as ATTRv.
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Timepoint [6]
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0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [7]
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Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 2
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Assessment method [7]
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Percentage of participants with ATTRwt were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with a result of 'no mutation' was considered as ATTRwt.
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Timepoint [7]
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During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [8]
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Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3
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Assessment method [8]
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Percentage of participants with ATTRwt were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with a result of 'no mutation' was considered as ATTRwt.
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Timepoint [8]
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During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [9]
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Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3.1
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Assessment method [9]
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Percentage of participants with ATTRwt were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with a result of 'no mutation' was considered as ATTRwt.
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Timepoint [9]
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0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [10]
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Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3.2
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Assessment method [10]
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Percentage of participants with ATTRwt were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with a result of 'no mutation' was considered as ATTRwt.
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Timepoint [10]
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0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [11]
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Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 2
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Assessment method [11]
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Scintigraphy is the procedure used to diagnose, stage, and monitor disease. A small amount of a radioactive chemical (radionuclide) was injected into a vein or swallowed. Number of participants with TTR genetic mutations among those who had positive scintigraphy were reported in this outcome measure.
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Timepoint [11]
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0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [12]
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Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 3
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Assessment method [12]
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Scintigraphy is the procedure used to diagnose, stage, and monitor disease. A small amount of a radioactive chemical (radionuclide) was injected into a vein or swallowed. Number of participants with TTR genetic mutations among those who had positive scintigraphy were reported in this outcome measure.
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Timepoint [12]
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0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [13]
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Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 3.1
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Assessment method [13]
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Scintigraphy is the procedure used to diagnose, stage, and monitor disease. A small amount of a radioactive chemical (radionuclide) was injected into a vein or swallowed. Number of participants with TTR genetic mutations among those who had positive scintigraphy were reported in this outcome measure.
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Timepoint [13]
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0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [14]
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Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 3.2
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Assessment method [14]
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0
Scintigraphy is the procedure used to diagnose, stage, and monitor disease. A small amount of a radioactive chemical (radionuclide) was injected into a vein or swallowed. Number of participants With TTR genetic mutations among those who had positive scintigraphy were reported in this outcome measure.
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Timepoint [14]
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0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [15]
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Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 1
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Assessment method [15]
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Percentage of participants with any of the familial history of known CM, PN or SCD among their relatives were reported in this outcome measure. Family history for each disease was considered for 1st degree parent, siblings, and 2nd/3rd grade family. CM was defined by the presence of a left ventricular (LV) wall thickness greater than or equal to (>=) 15 mm in one or more LV myocardial segments that is not explained solely by abnormal loading conditions. Polyneuropathy was defined as the simultaneous malfunction of many peripheral nerves throughout the body. SCD was defined as death due to a cardiovascular cause that occurs within one hour of the onset of symptoms. A sudden cardiac arrest occurs when the heart stops beating or is not beating sufficiently to maintain perfusion and life.
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Timepoint [15]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [16]
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0
Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 2
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Assessment method [16]
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0
Percentage of participants with any of the familial history of known CM, PN or SCD among their relatives were reported in this outcome measure. Family history for each disease was considered for 1st degree parent, siblings, and 2nd/3rd grade family. CM was defined by the presence of a LV wall thickness >= 15 mm in one or more LV myocardial segments that is not explained solely by abnormal loading conditions. Polyneuropathy was defined as the simultaneous malfunction of many peripheral nerves throughout the body. SCD was defined as death due to a cardiovascular cause that occurs within one hour of the onset of symptoms. A sudden cardiac arrest occurs when the heart stops beating or is not beating sufficiently to maintain perfusion and life.
Query!
Timepoint [16]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [17]
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Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 3
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Assessment method [17]
0
0
Percentage of participants with any of the familial history of known CM, PN or SCD among their relatives were reported in this outcome measure. Family history for each disease was considered for 1st degree parent, siblings, and 2nd/3rd grade family. CM was defined by the presence of a LV wall thickness >= 15 mm in one or more LV myocardial segments that is not explained solely by abnormal loading conditions. Polyneuropathy was defined as the simultaneous malfunction of many peripheral nerves throughout the body. SCD was defined as death due to a cardiovascular cause that occurs within one hour of the onset of symptoms. A sudden cardiac arrest occurs when the heart stops beating or is not beating sufficiently to maintain perfusion and life.
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Timepoint [17]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [18]
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Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 3.1
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Assessment method [18]
0
0
Percentage of participants with any of the familial history of known CM, PN or SCD among their relatives were reported in this outcome measure. Family history for each disease was considered for 1st degree parent, siblings, and 2nd/3rd grade family. CM was defined by the presence of a LV wall thickness >= 15 mm in one or more LV myocardial segments that is not explained solely by abnormal loading conditions. Polyneuropathy was defined as the simultaneous malfunction of many peripheral nerves throughout the body. SCD was defined as death due to a cardiovascular cause that occurs within one hour of the onset of symptoms. A sudden cardiac arrest occurs when the heart stops beating or is not beating sufficiently to maintain perfusion and life.
Query!
Timepoint [18]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [19]
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0
Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 3.2
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Assessment method [19]
0
0
Percentage of participants with any of the familial history of known CM, PN or SCD among their relatives were reported in this outcome measure. Family history for each disease was considered for 1st degree parent, siblings, and 2nd/3rd grade family. CM was defined by the presence of a LV wall thickness >= 15 mm in one or more LV myocardial segments that is not explained solely by abnormal loading conditions. Polyneuropathy was defined as the simultaneous malfunction of many peripheral nerves throughout the body. SCD was defined as death due to a cardiovascular cause that occurs within one hour of the onset of symptoms. A sudden cardiac arrest occurs when the heart stops beating or is not beating sufficiently to maintain perfusion and life.
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Timepoint [19]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [20]
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Percentage of Participants With Senso-Motor Polyneuropathy: FAS 2
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Assessment method [20]
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Participants with at least one red flag in the neurological part of the ATTR-Amyloidosis red flags Electronic Case Report Form (e-CRF) part was considered as participants with a senso-motor polyneuropathy.
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Timepoint [20]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [21]
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Percentage of Participants With Senso-Motor Polyneuropathy: FAS 3
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Assessment method [21]
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0
Participants with at least one red flag in the neurological part of the ATTR-Amyloidosis red flags e-CRF part was considered as participants with a senso-motor polyneuropathy.
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Timepoint [21]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [22]
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Percentage of Participants With Senso-Motor Polyneuropathy: FAS 3.1
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Assessment method [22]
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0
Participants with at least one red flag in the neurological part of the ATTR-Amyloidosis red flags e-CRF part was considered as participants with a senso-motor polyneuropathy.
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Timepoint [22]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [23]
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Percentage of Participants With Senso-Motor Polyneuropathy: FAS 3.2
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Assessment method [23]
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0
Participants with at least one red flag in the neurological part of the ATTR-Amyloidosis red flags e-CRF part was considered as participants with a senso-motor polyneuropathy.
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Timepoint [23]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [24]
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Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 2
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Assessment method [24]
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0
CTS was defined as a common neurological disorder that occurs when the median nerve, which runs from your forearm into the palm of the hand, becomes pressed or squeezed at the wrist. Participants with a CTS were participants with a bilateral or unilateral CTS.
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Timepoint [24]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [25]
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Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 3
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Assessment method [25]
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0
CTS was defined as a common neurological disorder that occurs when the median nerve, which runs from your forearm into the palm of the hand, becomes pressed or squeezed at the wrist. Participants with a CTS were participants with a bilateral or unilateral CTS.
Query!
Timepoint [25]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [26]
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0
Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 3.1
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Assessment method [26]
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0
CTS was defined as a common neurological disorder that occurs when the median nerve, which runs from your forearm into the palm of the hand, becomes pressed or squeezed at the wrist. Participants with a CTS were participants with a bilateral or unilateral CTS.
Query!
Timepoint [26]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [27]
0
0
Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 3.2
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Assessment method [27]
0
0
CTS was defined as a common neurological disorder that occurs when the median nerve, which runs from your forearm into the palm of the hand, becomes pressed or squeezed at the wrist. Participants with a CTS were participants with a bilateral or unilateral CTS.
Query!
Timepoint [27]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [28]
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0
Percentage of Participants With Autonomic Dysfunction: FAS 2
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Assessment method [28]
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0
Participants with autonomic dysfunction were participants with at least one autonomic sign or autonomic symptom = "Yes".
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Timepoint [28]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [29]
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Percentage of Participants With Autonomic Dysfunction: FAS 3
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Assessment method [29]
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0
Participants with autonomic dysfunction were participants with at least one autonomic sign or autonomic symptom = "Yes".
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Timepoint [29]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [30]
0
0
Percentage of Participants With Autonomic Dysfunction: FAS 3.1
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Assessment method [30]
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0
Participants with autonomic dysfunction were participants with at least one autonomic sign or autonomic symptom = "Yes".
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Timepoint [30]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [31]
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0
Percentage of Participants With Autonomic Dysfunction: FAS 3.2
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Assessment method [31]
0
0
Participants with autonomic dysfunction were participants with at least one autonomic sign or autonomic symptom = "Yes".
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Timepoint [31]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
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Secondary outcome [32]
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0
Percentage of Participants With Cardiological Manifestations: FAS 2
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Assessment method [32]
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0
Participants with cardiological manifestations was defined as participants with at least one of the following criteria fulfilled from data collected from e-CRF: cardiological assessments: atrial fibrillation (yes permanent), pacemaker (yes), AICD (yes); in magnetic resonance imaging (MRI) part: LGE (positive); electrocardiogram (ECG) part: PR interval less than (<) 80 milliseconds (ms) or greater than (>) 350 ms QRS interval < 60 ms or > 250 ms, Sokolow index < 1 mm or > 70 mm, pseudo MI pattern (yes), PPOr precordial R wave progression(yes), LBBB, RBBB, paced and intraventricular conduct delay (ticked), LVOT (yes), if longitudinal strain is done, strain apical preserved (yes), LV end-diastolic diameter <20 mm or >80 mm, MWT <15 mm or >100 mm, MWT at septum <3 mm or >50 mm, MWT posterior wall <3 mm or >50 mm, LV mass index <40 g/m^2 or >160 g/m^2, Maximal aortic velocity >5 m/s, Mean gradient of Aortic valvular stenosis >70 mmHg, Area of Aortic valvular stenosis <0.2 cm^2 or >3 cm^2.
Query!
Timepoint [32]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [33]
0
0
Percentage of Participants With Cardiological Manifestations: FAS 3
Query!
Assessment method [33]
0
0
Participants with cardiological manifestations was defined as participants with at least one of the following criteria fulfilled from data collected from e-CRF: cardiological assessments: atrial fibrillation (yes permanent), pacemaker (yes), AICD (yes); in magnetic resonance imaging (MRI) part: LGE (positive); electrocardiogram (ECG) part: PR interval < 80 ms or > 350 ms QRS interval < 60 ms or > 250 ms, Sokolow index < 1 mm or > 70 mm, pseudo MI pattern (yes), PPOr precordial R wave progression(yes), LBBB, RBBB, paced and intraventricular conduct delay (ticked), LVOT (yes), if longitudinal strain is done, strain apical preserved (yes), LV end-diastolic diameter <20 mm or >80 mm, MWT <15 mm or >100 mm, MWT at septum <3 mm or >50 mm, MWT posterior wall <3 mm or >50 mm, LV mass index <40 g/m^2 or >160 g/m^2, Maximal aortic velocity >5 m/s, Mean gradient of Aortic valvular stenosis >70 mmHg, Area of Aortic valvular stenosis <0.2 cm^2 or >3 cm^2.
Query!
Timepoint [33]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [34]
0
0
Percentage of Participants With Cardiological Manifestations: FAS 3.1
Query!
Assessment method [34]
0
0
Participants with cardiological manifestations was defined as participants with at least one of the following criteria fulfilled from data collected from e-CRF: cardiological assessments: atrial fibrillation (yes permanent), pacemaker (yes), AICD (yes); in magnetic resonance imaging (MRI) part: LGE (positive); electrocardiogram (ECG) part: PR interval < 80 ms or > 350 ms QRS interval < 60 ms or > 250 ms, Sokolow index < 1 mm or > 70 mm, pseudo MI pattern (yes), PPOr precordial R wave progression(yes), LBBB, RBBB, paced and intraventricular conduct delay (ticked), LVOT (yes), if longitudinal strain is done, strain apical preserved (yes), LV end-diastolic diameter <20 mm or >80 mm, MWT <15 mm or >100 mm, MWT at septum <3 mm or >50 mm, MWT posterior wall <3 mm or >50 mm, LV mass index <40 g/m^2 or >160 g/m^2, Maximal aortic velocity >5 m/s, Mean gradient of Aortic valvular stenosis >70 mmHg, Area of Aortic valvular stenosis <0.2 cm^2 or >3 cm^2.
Query!
Timepoint [34]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [35]
0
0
Percentage of Participants With Cardiological Manifestations: FAS 3.2
Query!
Assessment method [35]
0
0
Participants with cardiological manifestations was defined as participants with at least one of the following criteria fulfilled from data collected from e-CRF: cardiological assessments: atrial fibrillation (yes permanent), pacemaker (yes), AICD (yes); in magnetic resonance imaging (MRI) part: LGE (positive); electrocardiogram (ECG) part: PR interval < 80 ms or > 350 ms QRS interval < 60 ms or > 250 ms, Sokolow index < 1 mm or > 70 mm, pseudo MI pattern (yes), PPOr precordial R wave progression(yes), LBBB, RBBB, paced and intraventricular conduct delay (ticked), LVOT (yes), if longitudinal strain is done, strain apical preserved (yes), LV end-diastolic diameter <20 mm or >80 mm, MWT <15 mm or >100 mm, MWT at septum <3 mm or >50 mm, MWT posterior wall <3 mm or >50 mm, LV mass index <40 g/m^2 or >160 g/m^2, Maximal aortic velocity >5 m/s, Mean gradient of Aortic valvular stenosis >70 mmHg, Area of Aortic valvular stenosis <0.2 cm^2 or >3 cm^2.
Query!
Timepoint [35]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [36]
0
0
Percentage of Participants With Laboratory Abnormalities: FAS 2
Query!
Assessment method [36]
0
0
Laboratory parameters that were considered as out of range included creatinine <45 micromole per liter (µmol/L) or greater than 104 µmol/L w; haemoglobin, participants with a value lower than 11.5 grams per deciliter (g/dL) or higher than 16 g/dL was considered as out of range; Brain natriuretic peptide (BNP) value higher than 100 picograms per milliliter (pg/mL); N-terminal pro-brain natriuretic peptide (NTproBNP), value higher than 125 pg/mL; Troponin I value higher than 26 pg/mL.
Query!
Timepoint [36]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [37]
0
0
Percentage of Participants With Laboratory Abnormalities: FAS 3
Query!
Assessment method [37]
0
0
Laboratory parameters that were considered as out of range included creatinine <45 µmol/L or greater than 104 µmol/L w; haemoglobin value lower than 11.5 g/dL or higher than 16 g/dL was considered as out of range; Brain natriuretic peptide (BNP) value higher than 100 pg/mL; N-terminal pro-brain natriuretic peptide (NTproBNP), value higher than 125 pg/mL; Troponin I value higher than 26 pg/mL.
Query!
Timepoint [37]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [38]
0
0
Percentage of Participants With Laboratory Abnormalities: FAS 3.1
Query!
Assessment method [38]
0
0
Laboratory parameters that were considered as out of range included creatinine <45 µmol/L or greater than 104 µmol/L w; haemoglobin value lower than 11.5 g/dL or higher than 16 g/dL was considered as out of range; Brain natriuretic peptide (BNP) value higher than 100 pg/mL; N-terminal pro-brain natriuretic peptide (NTproBNP), value higher than 125 pg/mL; Troponin I value higher than 26 pg/mL.
Query!
Timepoint [38]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [39]
0
0
Percentage of Participants With Laboratory Abnormalities: FAS 3.2
Query!
Assessment method [39]
0
0
Laboratory parameters that were considered as out of range included creatinine <45 µmol/L or greater than 104 µmol/L w; haemoglobin value lower than 11.5 g/dL or higher than 16 g/dL was considered as out of range; Brain natriuretic peptide (BNP) value higher than 100 pg/mL; N-terminal pro-brain natriuretic peptide (NTproBNP), value higher than 125 pg/mL; Troponin I value higher than 26 pg/mL.
Query!
Timepoint [39]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [40]
0
0
Number of Participants According to Presence of Neurological Red Flag: FAS1
Query!
Assessment method [40]
0
0
Participants were classified according to presence of neurological red flag as 'Yes' or 'No'.
Query!
Timepoint [40]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [41]
0
0
Number of Participants According to Presence of Neurological Red Flag: FAS 2
Query!
Assessment method [41]
0
0
Participants were classified according to presence of neurological red flag as 'Yes' or 'No'.
Query!
Timepoint [41]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [42]
0
0
Number of Participants According to Discrepancies Between Scintigraphy Result and Single Photon Emission Computed Tomography (SPECT) Result: FAS1
Query!
Assessment method [42]
0
0
Grade of scintigraphy evaluated by the investigator and Grade of SPECT: Grade 0 = absent cardiac uptake, Grade 1=mild uptake less than bone, Grade 2=moderate uptake equal to bone and Grade 3=high uptake greater than bone. Only categories with non-zero values were reported.
Query!
Timepoint [42]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [43]
0
0
Cardiological Assessments - Blood Pressure: FAS 2
Query!
Assessment method [43]
0
0
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were evaluated.
Query!
Timepoint [43]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [44]
0
0
Cardiological Assessments - Blood Pressure: FAS 3
Query!
Assessment method [44]
0
0
SBP and DBP were evaluated.
Query!
Timepoint [44]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [45]
0
0
Cardiological Assessments - Blood Pressure: FAS 3.1
Query!
Assessment method [45]
0
0
SBP and DBP were evaluated.
Query!
Timepoint [45]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [46]
0
0
Cardiological Assessments - Blood Pressure: FAS 3.2
Query!
Assessment method [46]
0
0
SBP and DBP were evaluated.
Query!
Timepoint [46]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [47]
0
0
Number of Participants According to History of Clinical Parameters at Baseline: FAS 2
Query!
Assessment method [47]
0
0
Clinical parameters' assessment for hypertension, antihypertensive medication, coronary artery disease, renal insufficiency, diabetes mellitus, lumbar spinal stenosis, carpal tunnel syndrome was categorized as 'Yes' and 'No', where Yes indicated presence and No indicated absence.
Query!
Timepoint [47]
0
0
Baseline
Query!
Secondary outcome [48]
0
0
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3
Query!
Assessment method [48]
0
0
Clinical parameters' assessment for hypertension, antihypertensive medication, coronary artery disease, renal insufficiency, diabetes mellitus, lumbar spinal stenosis, carpal tunnel syndrome was categorized as 'Yes' and 'No', where Yes indicated presence and No indicated absence.
Query!
Timepoint [48]
0
0
Baseline
Query!
Secondary outcome [49]
0
0
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1
Query!
Assessment method [49]
0
0
Clinical parameters' assessment for hypertension, antihypertensive medication, coronary artery disease, renal insufficiency, diabetes mellitus, lumbar spinal stenosis, carpal tunnel syndrome was categorized as 'Yes' and 'No', where Yes indicated presence and No indicated absence.
Query!
Timepoint [49]
0
0
Baseline
Query!
Secondary outcome [50]
0
0
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2
Query!
Assessment method [50]
0
0
Clinical parameters' assessment for hypertension, antihypertensive medication, coronary artery disease, renal insufficiency, diabetes mellitus, lumbar spinal stenosis, carpal tunnel syndrome was categorized as 'Yes' and 'No', where Yes indicated presence and No indicated absence.
Query!
Timepoint [50]
0
0
Baseline
Query!
Secondary outcome [51]
0
0
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 2
Query!
Assessment method [51]
0
0
Participants classified according to NYHA class as Class I, Class II, Class III, Class IV were reported in this outcome measure. Class I: no symptoms and no limitation in ordinary physical activity, such as shortness of breath when walking, climbing stairs. Class II: mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: marked limitation in activity due to symptoms, even during less-than-ordinary activity, such as walking short distances (20-100 meters), comfortable only at rest. Class IV: severe limitations and experienced symptoms even while at rest, mostly bedbound participants.
Query!
Timepoint [51]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [52]
0
0
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3
Query!
Assessment method [52]
0
0
Participants classified according to NYHA class as Class I, Class II, Class III, Class IV were reported in this outcome measure. Class I: no symptoms and no limitation in ordinary physical activity, such as shortness of breath when walking, climbing stairs. Class II: mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: marked limitation in activity due to symptoms, even during less-than-ordinary activity, such as walking short distances (20-100 meters), comfortable only at rest. Class IV: severe limitations and experienced symptoms even while at rest, mostly bedbound participants.
Query!
Timepoint [52]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [53]
0
0
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.1
Query!
Assessment method [53]
0
0
Participants classified according to NYHA class as Class I, Class II, Class III, Class IV were reported in this outcome measure. Class I: no symptoms and no limitation in ordinary physical activity, such as shortness of breath when walking, climbing stairs. Class II: mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: marked limitation in activity due to symptoms, even during less-than-ordinary activity, such as walking short distances (20-100 meters), comfortable only at rest. Class IV: severe limitations and experienced symptoms even while at rest, mostly bedbound participants.
Query!
Timepoint [53]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [54]
0
0
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.2
Query!
Assessment method [54]
0
0
Participants classified according to NYHA class as Class I, Class II, Class III, Class IV were reported in this outcome measure. Class I: no symptoms and no limitation in ordinary physical activity, such as shortness of breath when walking, climbing stairs. Class II: mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: marked limitation in activity due to symptoms, even during less-than-ordinary activity, such as walking short distances (20-100 meters), comfortable only at rest. Class IV: severe limitations and experienced symptoms even while at rest, mostly bedbound participants.
Query!
Timepoint [54]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [55]
0
0
Number of Participants With Atrial Fibrillation Assessment: FAS 2
Query!
Assessment method [55]
0
0
Participants were classified according to presence of atrial fibrillation as 'No', 'Yes permanent', 'Yes in the past' and were reported in this outcome measure.
Query!
Timepoint [55]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [56]
0
0
Number of Participants With Atrial Fibrillation Assessment: FAS 3
Query!
Assessment method [56]
0
0
Participants were classified according to presence of atrial fibrillation as 'No', 'Yes permanent', 'Yes in the past' and were reported in this outcome measure.
Query!
Timepoint [56]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [57]
0
0
Number of Participants With Atrial Fibrillation Assessment: FAS 3.1
Query!
Assessment method [57]
0
0
Participants were classified according to presence of atrial fibrillation as 'No', 'Yes permanent', 'Yes in the past' and were reported in this outcome measure.
Query!
Timepoint [57]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [58]
0
0
Number of Participants With Atrial Fibrillation Assessment: FAS 3.2
Query!
Assessment method [58]
0
0
Participants were classified according to presence of atrial fibrillation as 'No', 'Yes permanent', 'Yes in the past' and were reported in this outcome measure.
Query!
Timepoint [58]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [59]
0
0
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 2
Query!
Assessment method [59]
0
0
Participants who used pacemaker and ICD were reported in this outcome measure.
Query!
Timepoint [59]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [60]
0
0
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3
Query!
Assessment method [60]
0
0
Participants who used pacemaker and ICD were reported in this outcome measure.
Query!
Timepoint [60]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [61]
0
0
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.1
Query!
Assessment method [61]
0
0
Participants who used pacemaker and ICD were reported in this outcome measure.
Query!
Timepoint [61]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [62]
0
0
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.2
Query!
Assessment method [62]
0
0
Participants who used pacemaker and ICD were reported in this outcome measure.
Query!
Timepoint [62]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [63]
0
0
Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 2
Query!
Assessment method [63]
0
0
Participants with MRI scan performed using LGE classified as 'negative' and 'positive' were reported in this outcome measure. LGE was defined as method where cardiovascular magnetic resonance (CMR) images were obtained after the administration of gadolinium contrast material that accumulated into a tissue with increased extra cellular space.
Query!
Timepoint [63]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [64]
0
0
Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3
Query!
Assessment method [64]
0
0
Participants with MRI scan performed using LGE classified as 'negative' and 'positive' were reported in this outcome measure. LGE was defined as method where cardiovascular magnetic resonance (CMR) images were obtained after the administration of gadolinium contrast material that accumulated into a tissue with increased extra cellular space.
Query!
Timepoint [64]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [65]
0
0
Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3.1
Query!
Assessment method [65]
0
0
Participants with MRI scan performed using LGE classified as 'negative' and 'positive' were reported in this outcome measure. LGE was defined as method where cardiovascular magnetic resonance (CMR) images were obtained after the administration of gadolinium contrast material that accumulated into a tissue with increased extra cellular space.
Query!
Timepoint [65]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [66]
0
0
Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3.2
Query!
Assessment method [66]
0
0
Participants with MRI scan performed using LGE classified as 'negative' and 'positive' were reported in this outcome measure. LGE was defined as method where cardiovascular magnetic resonance (CMR) images were obtained after the administration of gadolinium contrast material that accumulated into a tissue with increased extra cellular space.
Query!
Timepoint [66]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [67]
0
0
Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 2
Query!
Assessment method [67]
0
0
Participants classified according to assessment for ECG for paced participants as 'Yes' or 'No' were reported in this outcome measure.
Query!
Timepoint [67]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [68]
0
0
Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3
Query!
Assessment method [68]
0
0
Participants classified according to assessment for ECG for paced participants as 'Yes' or 'No' were reported in this outcome measure.
Query!
Timepoint [68]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [69]
0
0
Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3.1
Query!
Assessment method [69]
0
0
Participants classified according to assessment for ECG for paced participants as 'Yes' or 'No' were reported in this outcome measure.
Query!
Timepoint [69]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [70]
0
0
Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3.2
Query!
Assessment method [70]
0
0
Participants classified according to assessment for ECG for paced participants as 'Yes' or 'No' were reported in this outcome measure.
Query!
Timepoint [70]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [71]
0
0
Heart Rate Parameter for Participants Without Paced: FAS 2
Query!
Assessment method [71]
0
0
Query!
Timepoint [71]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [72]
0
0
Heart Rate Parameter for Participants Without Paced: FAS 3
Query!
Assessment method [72]
0
0
Query!
Timepoint [72]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [73]
0
0
Heart Rate Parameter for Participants Without Paced: FAS 3.1
Query!
Assessment method [73]
0
0
Query!
Timepoint [73]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [74]
0
0
Heart Rate Parameter for Participants Without Paced: FAS 3.2
Query!
Assessment method [74]
0
0
Query!
Timepoint [74]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [75]
0
0
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 2
Query!
Assessment method [75]
0
0
Query!
Timepoint [75]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [76]
0
0
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3
Query!
Assessment method [76]
0
0
Query!
Timepoint [76]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [77]
0
0
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.1
Query!
Assessment method [77]
0
0
Query!
Timepoint [77]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [78]
0
0
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.2
Query!
Assessment method [78]
0
0
Query!
Timepoint [78]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [79]
0
0
Sokolow Index: FAS 2
Query!
Assessment method [79]
0
0
Sokolow index is calculated as sum of the amplitude of the S wave in in right precordial lead V1 and the amplitude of the highest R wave in left precordial leads V5 or V6. If the result is greater than 35 mm, it is suggestive of left ventricular hypertrophy.
Query!
Timepoint [79]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [80]
0
0
Sokolow Index: FAS 3
Query!
Assessment method [80]
0
0
Sokolow index is calculated as sum of the amplitude of the S wave in in right precordial lead V1 and the amplitude of the highest R wave in left precordial leads V5 or V6. If the result is greater than 35 mm, it is suggestive of left ventricular hypertrophy.
Query!
Timepoint [80]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [81]
0
0
Sokolow Index: FAS 3.1
Query!
Assessment method [81]
0
0
Sokolow index is calculated as sum of the amplitude of the S wave in in right precordial lead V1 and the amplitude of the highest R wave in left precordial leads V5 or V6. If the result is greater than 35 mm, it is suggestive of left ventricular hypertrophy.
Query!
Timepoint [81]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [82]
0
0
Sokolow Index: FAS 3.2
Query!
Assessment method [82]
0
0
Sokolow index is calculated as sum of the amplitude of the S wave in in right precordial lead V1 and the amplitude of the highest R wave in left precordial leads V5 or V6. If the result is greater than 35 mm, it is suggestive of left ventricular hypertrophy.
Query!
Timepoint [82]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [83]
0
0
Left Ventricular Ejection Fraction (LVEF): FAS 2
Query!
Assessment method [83]
0
0
LVEF was defined as the central measure of left ventricular systolic function. LVEF was the fraction of stroke volume (volume ejected in systole) in relation to the volume of the blood in the ventricle at the end of diastole volume (EDV). LVEF was presented in percentage.
Query!
Timepoint [83]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [84]
0
0
Left Ventricular Ejection Fraction (LVEF): FAS 3
Query!
Assessment method [84]
0
0
LVEF was defined as the central measure of left ventricular systolic function. LVEF was the fraction of stroke volume (volume ejected in systole) in relation to the volume of the blood in the ventricle at the end of diastole volume (EDV). LVEF was presented in percentage.
Query!
Timepoint [84]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [85]
0
0
Left Ventricular Ejection Fraction (LVEF): FAS 3.1
Query!
Assessment method [85]
0
0
LVEF was defined as the central measure of left ventricular systolic function. LVEF was the fraction of stroke volume (volume ejected in systole) in relation to the volume of the blood in the ventricle at the end of diastole volume (EDV). LVEF was presented in percentage.
Query!
Timepoint [85]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [86]
0
0
Left Ventricular Ejection Fraction (LVEF): FAS 3.2
Query!
Assessment method [86]
0
0
LVEF was defined as the central measure of left ventricular systolic function. LVEF was the fraction of stroke volume (volume ejected in systole) in relation to the volume of the blood in the ventricle at the end of diastole volume (EDV). LVEF was presented in percentage.
Query!
Timepoint [86]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [87]
0
0
Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 2
Query!
Assessment method [87]
0
0
LVOT is defined as limitation of blood flow out of the left ventricle. The level of obstruction can be valvular, sub-valvular, or supravalvular. In this outcome measure participants were categorized as Yes or No on the basis of presence or absence of LVOT.
Query!
Timepoint [87]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [88]
0
0
Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3
Query!
Assessment method [88]
0
0
LVOT is defined as limitation of blood flow out of the left ventricle. The level of obstruction can be valvular, sub-valvular, or supravalvular. In this outcome measure participants were categorized as Yes or No on the basis of presence or absence of LVOT.
Query!
Timepoint [88]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [89]
0
0
Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3.1
Query!
Assessment method [89]
0
0
LVOT is defined as limitation of blood flow out of the left ventricle. The level of obstruction can be valvular, sub-valvular, or supravalvular. In this outcome measure participants were categorized as Yes or No on the basis of presence or absence of LVOT.
Query!
Timepoint [89]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [90]
0
0
Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3.2
Query!
Assessment method [90]
0
0
LVOT is defined as limitation of blood flow out of the left ventricle. The level of obstruction can be valvular, sub-valvular, or supravalvular. In this outcome measure participants were categorized as Yes or No on the basis of presence or absence of LVOT.
Query!
Timepoint [90]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [91]
0
0
Number of Participants Categorized According to Perseverance of Strain Apical: FAS 2
Query!
Assessment method [91]
0
0
Participants were classified according to strain apical preserved as 'No' and 'Yes'.
Query!
Timepoint [91]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [92]
0
0
Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3
Query!
Assessment method [92]
0
0
Participants were classified according to strain apical preserved as 'No' and 'Yes'.
Query!
Timepoint [92]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [93]
0
0
Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3.1
Query!
Assessment method [93]
0
0
Participants were classified according to strain apical preserved as 'No' and 'Yes'.
Query!
Timepoint [93]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [94]
0
0
Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3.2
Query!
Assessment method [94]
0
0
Participants were classified according to strain apical preserved as 'No' and 'Yes'.
Query!
Timepoint [94]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [95]
0
0
LV End Diastolic Diameter: FAS 2
Query!
Assessment method [95]
0
0
Left ventricular end-diastolic diameter (LVEDD) reflects the size of cardiac as well as left ventricular function. It was associated with progressive left ventricular insufficiency.
Query!
Timepoint [95]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [96]
0
0
LV End Diastolic Diameter: FAS 3
Query!
Assessment method [96]
0
0
LVEDD reflects the size of cardiac as well as left ventricular function. It was associated with progressive left ventricular insufficiency.
Query!
Timepoint [96]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [97]
0
0
LV End Diastolic Diameter: FAS 3.1
Query!
Assessment method [97]
0
0
LVEDD reflects the size of cardiac as well as left ventricular function. It was associated with progressive left ventricular insufficiency.
Query!
Timepoint [97]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [98]
0
0
LV End Diastolic Diameter: FAS 3.2
Query!
Assessment method [98]
0
0
LVEDD reflects the size of cardiac as well as left ventricular function. It was associated with progressive left ventricular insufficiency.
Query!
Timepoint [98]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [99]
0
0
Maximum Wall Thickness: FAS 2
Query!
Assessment method [99]
0
0
Query!
Timepoint [99]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [100]
0
0
Maximum Wall Thickness: FAS 3
Query!
Assessment method [100]
0
0
Query!
Timepoint [100]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [101]
0
0
Maximum Wall Thickness: FAS 3.1
Query!
Assessment method [101]
0
0
Query!
Timepoint [101]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [102]
0
0
Maximum Wall Thickness: FAS 3.2
Query!
Assessment method [102]
0
0
Query!
Timepoint [102]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [103]
0
0
Number of Participants According to Type of Hypertrophic Pattern: FAS 2
Query!
Assessment method [103]
0
0
Participants were classified according to hypertrophic pattern as apical, concentric, asymmetric and mix.
Query!
Timepoint [103]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [104]
0
0
Number of Participants According to Type of Hypertrophic Pattern: FAS 3
Query!
Assessment method [104]
0
0
Participants were classified according to hypertrophic pattern as apical, concentric, asymmetric and mix.
Query!
Timepoint [104]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [105]
0
0
Number of Participants According to Type of Hypertrophic Pattern: FAS 3.1
Query!
Assessment method [105]
0
0
Participants were classified according to hypertrophic pattern as apical, concentric, asymmetric and mix.
Query!
Timepoint [105]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [106]
0
0
Number of Participants According to Type of Hypertrophic Pattern: FAS 3.2
Query!
Assessment method [106]
0
0
Participants were classified according to hypertrophic pattern as apical, concentric, asymmetric and mix.
Query!
Timepoint [106]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [107]
0
0
LV Mass Index (LVMI): FAS 2
Query!
Assessment method [107]
0
0
Left ventricular mass (LVM) is the weight of the left ventricle, typically estimated using echocardiography, and is thought to represent the cumulative effect of blood pressure on the heart. Closely related to body size, greater in men than in women, and increases with age. LVMI = LVM (left ventricular mass)/body surface area.
Query!
Timepoint [107]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [108]
0
0
LV Mass Index (LVMI): FAS 3
Query!
Assessment method [108]
0
0
Left ventricular mass (LVM) is the weight of the left ventricle, typically estimated using echocardiography, and is thought to represent the cumulative effect of blood pressure on the heart. Closely related to body size, greater in men than in women, and increases with age. LVMI = LVM (left ventricular mass)/body surface area.
Query!
Timepoint [108]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [109]
0
0
LV Mass Index (LVMI): FAS 3.1
Query!
Assessment method [109]
0
0
Left ventricular mass (LVM) is the weight of the left ventricle, typically estimated using echocardiography, and is thought to represent the cumulative effect of blood pressure on the heart. Closely related to body size, greater in men than in women, and increases with age. LVMI = LVM (left ventricular mass)/body surface area.
Query!
Timepoint [109]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [110]
0
0
LV Mass Index (LVMI): FAS 3.2
Query!
Assessment method [110]
0
0
Left ventricular mass (LVM) is the weight of the left ventricle, typically estimated using echocardiography, and is thought to represent the cumulative effect of blood pressure on the heart. Closely related to body size, greater in men than in women, and increases with age. LVMI = LVM (left ventricular mass)/body surface area.
Query!
Timepoint [110]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [111]
0
0
Aortic Valvular Stenosis - Aortic Valve Area: FAS 2
Query!
Assessment method [111]
0
0
Aortic valve stenosis is a type of heart valve disease (valvular heart disease). The valve between the lower left heart chamber and the body's main artery (aorta) is narrowed and doesn't open fully. This reduces or blocks blood flow from the heart to the aorta and to the rest of the body. Parameters needed to classify the aortic valve stenosis: peak transvalvular velocity, mean pressure gradient and aortic valve area. Here, aortic valve area is reported in this outcome measure.
Query!
Timepoint [111]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [112]
0
0
Aortic Valvular Stenosis - Aortic Valve Area: FAS 3
Query!
Assessment method [112]
0
0
Aortic valve stenosis is a type of heart valve disease (valvular heart disease). The valve between the lower left heart chamber and the body's main artery (aorta) is narrowed and doesn't open fully. This reduces or blocks blood flow from the heart to the aorta and to the rest of the body. Parameters needed to classify the aortic valve stenosis: peak transvalvular velocity, mean pressure gradient and aortic valve area. Here, aortic valve area is reported in this outcome measure.
Query!
Timepoint [112]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [113]
0
0
Aortic Valvular Stenosis - Aortic Valve Area: FAS 3.1
Query!
Assessment method [113]
0
0
Aortic valve stenosis is a type of heart valve disease (valvular heart disease). The valve between the lower left heart chamber and the body's main artery (aorta) is narrowed and doesn't open fully. This reduces or blocks blood flow from the heart to the aorta and to the rest of the body. Parameters needed to classify the aortic valve stenosis: peak transvalvular velocity, mean pressure gradient and aortic valve area. Here, aortic valve area is reported in this outcome measure.
Query!
Timepoint [113]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Secondary outcome [114]
0
0
Aortic Valvular Stenosis - Aortic Valve Area: FAS 3.2
Query!
Assessment method [114]
0
0
Aortic valve stenosis is a type of heart valve disease (valvular heart disease). The valve between the lower left heart chamber and the body's main artery (aorta) is narrowed and doesn't open fully. This reduces or blocks blood flow from the heart to the aorta and to the rest of the body. Parameters needed to classify the aortic valve stenosis: peak transvalvular velocity, mean pressure gradient and aortic valve area. Here, aortic valve area is reported in this outcome measure.
Query!
Timepoint [114]
0
0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Query!
Eligibility
Key inclusion criteria
Inclusion criteria:
- Patient signed inform consent.
- Males and Females.
- Age =50 years.
- Left ventricular hypertrophy (LVH) defined as end-diastolic LV maximum wall thickness
(MWT) =15mm in Echocardiogram.
- Plan to undergo or recently underwent radionuclide bone scintigraphy and/or SPECT with
any of the following radio labelled tracers: 99mTc-DPD or 99mTc-PYP or 99mTc-HMDP.
Query!
Minimum age
50
Years
Query!
Query!
Maximum age
99
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Exclusion criteria:
- Etiological diagnosis explaining the LVH (p.e. Sarcomeric HCM, Myeloma, Fabry disease,
Sarcoidosis, Any type of amyloidosis (AA, AL, TTR)
- Severe aortic stenosis defined as aortic valve area (AVA) < 1.0 cm2
Query!
Study design
Purpose
Query!
Duration
Cross-sectional
Query!
Selection
Query!
Timing
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
9/07/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
8/06/2022
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
812
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
The Prince Charles Hospital - Chermside
Query!
Recruitment hospital [2]
0
0
The Alfred Department of Cardiology - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
4102 - Chermside
Query!
Recruitment postcode(s) [2]
0
0
- Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
Austria
Query!
State/province [1]
0
0
Innsbruck
Query!
Country [2]
0
0
France
Query!
State/province [2]
0
0
Cedex
Query!
Country [3]
0
0
France
Query!
State/province [3]
0
0
Creteil
Query!
Country [4]
0
0
France
Query!
State/province [4]
0
0
Nantes cedex 1
Query!
Country [5]
0
0
France
Query!
State/province [5]
0
0
Toulouse
Query!
Country [6]
0
0
Italy
Query!
State/province [6]
0
0
Bologna
Query!
Country [7]
0
0
Italy
Query!
State/province [7]
0
0
Florence
Query!
Country [8]
0
0
Portugal
Query!
State/province [8]
0
0
Coimbra
Query!
Country [9]
0
0
Portugal
Query!
State/province [9]
0
0
Lisboa
Query!
Country [10]
0
0
Romania
Query!
State/province [10]
0
0
Bucharest
Query!
Country [11]
0
0
Slovakia
Query!
State/province [11]
0
0
Kosice
Query!
Country [12]
0
0
Slovenia
Query!
State/province [12]
0
0
Ljubljana
Query!
Country [13]
0
0
Spain
Query!
State/province [13]
0
0
Madrid
Query!
Country [14]
0
0
Spain
Query!
State/province [14]
0
0
A Coruna
Query!
Country [15]
0
0
United Kingdom
Query!
State/province [15]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Pfizer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The main purpose of this study is to determine the prevalence of ATTR Cardiomyopathy among
patients admitted due to Left Ventricular Hypertrophy (LVH) >15mm of unknown etiology by
using a 99mTc-tracer scintigraphy based protocol
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03842163
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03842163
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