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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/NCT01736540
Registration number
NCT01736540
Ethics application status
Date submitted
26/11/2012
Date registered
29/11/2012
Date last updated
12/04/2017
Titles & IDs
Public title
An Epidemiological Study to Assess Iron Overload Using MRI in Patients With Transfusional Siderosis (TIMES Study)
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Scientific title
An Epidemiological Study to Assess the Prevalence of Iron Overload Using MRI in Patients With Transfusional Siderosis (TIMES Study)
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Secondary ID [1]
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CICL670AAU05
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Thalassemia, Non-transfusional-dependent Thalassemia (NTDT), Myeloplastic Dysplasia (MDS), Other Anemia
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Blood
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Haematological diseases
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Blood
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Other blood disorders
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Metabolic and Endocrine
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Metabolic disorders
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Metabolic and Endocrine
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Other metabolic disorders
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Diet and Nutrition
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Other diet and nutrition disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - MRI scan
Other: Magnetic Resonance Imaging (MRI) - All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
Treatment: Devices: MRI scan
MRI was used to measure both liver and cardiac iron loading (R2 by FerriScan and T2*, respectively).
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Intervention code [1]
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Treatment: Devices
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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 and Liver Iron Overload.
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Assessment method [1]
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Hepatic iron overload (liver siderosis) and cardiac iron overload (cardiac siderosis) in patients with transfusional siderosis (Myelodysplastic syndrome (MDS), thalassaemia major, non-transfusion-dependent thalassaemia (NTDT) and other anaemias) were measured using MRI (R2 by FerriScan and T2*, respectively).
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Timepoint [1]
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2 months
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Primary outcome [2]
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Cardiac Siderosis Severity
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Assessment method [2]
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Cardiac siderosis severity was measured by MRI (T2*). The severity grade of siderosis was tiered in 3 levels: mild (T2* >= 20ms), moderate (T2* from 10 to 20ms), and severe (T2* <10ms). Mild cardiac siderosis, by the definitions used in this study, were equivalent to not having cardiac siderosis. Values were compared to published thresholds of iron overload to determine severity of transfusion siderosis in the participant population studied.
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Timepoint [2]
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2 months
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Secondary outcome [1]
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Comparison of T2* Levels to Evaluate the Severity of Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups
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Assessment method [1]
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Iron overload due to transfusion therapy was assessed based on chelation status of each participant (i.e. minimally exposed to chelator treatment and chelation-treated patient subgroups).
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Timepoint [1]
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2 months
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Secondary outcome [2]
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Comparison of Liver Iron Concentration (LIC) Levels to Evaluate Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups
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Assessment method [2]
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Iron overload due to transfusion therapy was assessed based on chelation status of each participant (i.e. minimally exposed to chelator treatment and chelation-treated patient subgroups). The mean data presented are mean estimates of log transformed data.
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Timepoint [2]
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2 months
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Secondary outcome [3]
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Mean Serum Ferritin According to the Presence or Absence of Retrospective Cardiac Events
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Assessment method [3]
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Mean serum ferritin according to the presence or absence of cardiac events was assessed for all participant subgroups.
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Timepoint [3]
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12 months - retrospective
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Secondary outcome [4]
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Mean Serum Ferritin According to the Presence or Absence of Retrospective Hepatic Events
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Assessment method [4]
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Mean serum ferritin according to the presence or absence of hepatic events was assessed for all participant subgroups.
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Timepoint [4]
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12 months - retrospective
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Secondary outcome [5]
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Mean Cardiac T2* According to the Presence or Absence of Retrospective Cardiac Events
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Assessment method [5]
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Mean cardiac T2* according to the presence or absence of cardiac events was assessed for all participant subgroups. The mean data presented are mean estimates of log transformed data.
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Timepoint [5]
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12 months - retrospective
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Secondary outcome [6]
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Mean LIC According to the Presence or Absence of Retrospective Hepatic Events
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Assessment method [6]
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Mean LIC according to the presence or absence of hepatic events was assessed for all participant subgroups.
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Timepoint [6]
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12 months - retrospective
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Secondary outcome [7]
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Mean Blood Magnetic Susceptibility (BMS)
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Assessment method [7]
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Blood samples were collected to assess BMS. The measurement represents absolute magnetic susceptibility at 1 month. Whole blood magnetic susceptibility was calculated by the addition of the dry weight susceptibility and the contribution of the water driven from the sample.
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Timepoint [7]
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1 month
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Secondary outcome [8]
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Percentage of Participants Transfused With Erythrocytes
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Assessment method [8]
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Transfusion requirement in participants with acquired anaemias with history of receiving chelation therapy was assessed.
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Timepoint [8]
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12 months - retrospective
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Secondary outcome [9]
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Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days
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Assessment method [9]
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Transfusion requirement in participants with acquired anaemias with history of receiving chelation therapy was assessed.
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Timepoint [9]
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12 months - retrospective
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Secondary outcome [10]
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Mean Number of Erythrocyte Units Transfused in Last 12 Months
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Assessment method [10]
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Transfusion requirement in participants with acquired anaemias with history of receiving chelation therapy was assessed.
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Timepoint [10]
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12 months - retrospective
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Secondary outcome [11]
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Mean Quality of Life (QOL) Scores
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Assessment method [11]
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Quality of life was assessed using the Short Form 36 (SF-36) Health Survey. The SF-36 consists of 8 sub-scales: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. The raw sores of the 8 scales are transformed to a 0 - 100 scale where 0 indicates maximum disability and 100 indicates no disability. There also are two physical and mental health summary measures. Each summary measure is the mean average of the 4 associated sub-scale scores. The range for each summary measure is 0 to 100 where 0 represents maximum disability and 100 represents no disability.
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Timepoint [11]
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1 month
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Secondary outcome [12]
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Percentage of Participants With Low Medium or High Adherence to Iron Chelator Therapy
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Assessment method [12]
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Adherence of participants was assessed using an adherence questionnaire. Adherence questionnaires were completed only by participants who received chelating agents. Participants answered yes or no to 6 statements such as "Forgot to take pills". Based on the responses to these questions, adherence was classified as low, medium or high.
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Timepoint [12]
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1 month
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Secondary outcome [13]
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Investigator Treatment Decisions Based on MRI Results
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Assessment method [13]
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Treatment decisions were recorded after the investigator evaluated the MRI results, in order to assess the impact of such diagnostic test on the overall clinical management of participants with iron overload. Investigators answered the following question: "Since the MRI scan, have you changed or are planning to change the management of iron in your subject?".
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Timepoint [13]
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2 months
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Eligibility
Key inclusion criteria
- Age =18 years
- Confirmed clinical diagnosis of one of the following disease states: 1.
Myelodysplastic syndromes, 2. Thalassaemia major, 3.Other anaemias (e.g. NTDT, SCD,
Diamond-Blackfan anaemia, aplastic anaemia, myeloproliferative disease)
- Lifetime history of at least 20 units of red blood cell transfusions AND serum
ferritin level > 500 ng/ml; patients with NTDT are not required to have a minimum of
20 units of red blood cell transfusions, but must have serum ferritin level > 300
ng/ml (serum ferritin for all patients must be measured up to 1 month prior to
enrollment)
- Written informed consent obtained prior to any procedure required by this protocol
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Any condition that does not allow the MRI test to be performed: 1. Cardiac pacemaker, 2.
Ferromagnetic metal implants other than those approved as safe for use in MR scanners
(Example: some types of aneurysm clips, shrapnel), 3. Obesity (exceeding the equipment
limits), 4. Patients who are claustrophobic to MR Women who are pregnant Unwillingness or
being unable to give consent
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Study design
Purpose of the study
Other
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2015
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Sample size
Target
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Accrual to date
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Final
243
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Novartis Investigative Site - Camperdown
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Recruitment hospital [2]
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Novartis Investigative Site - Kogarah
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Recruitment hospital [3]
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Novartis Investigative Site - Liverpool
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Recruitment hospital [4]
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Novartis Investigative Site - St Leonards
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Recruitment hospital [5]
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Novartis Investigative Site - Wollongong
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Recruitment hospital [6]
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Novartis Investigative Site - South Brisbane
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Recruitment hospital [7]
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Novartis Investigative Site - Woolloongabba
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Recruitment hospital [8]
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Novartis Investigative Site - Adelaide
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Recruitment hospital [9]
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Novartis Investigative Site - Bedford Park
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Recruitment hospital [10]
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Novartis Investigative Site - Hobart
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Recruitment hospital [11]
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Novartis Investigative Site - East Bentleigh
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Recruitment hospital [12]
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Novartis Investigative Site - Nedlands
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Recruitment hospital [13]
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Novartis Investigative Site - Perth
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2217 - Kogarah
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Recruitment postcode(s) [3]
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2170 - Liverpool
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Recruitment postcode(s) [4]
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2065 - St Leonards
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Recruitment postcode(s) [5]
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2500 - Wollongong
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Recruitment postcode(s) [6]
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4101 - South Brisbane
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Recruitment postcode(s) [7]
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4102 - Woolloongabba
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Recruitment postcode(s) [8]
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5000 - Adelaide
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Recruitment postcode(s) [9]
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5042 - Bedford Park
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Recruitment postcode(s) [10]
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7000 - Hobart
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Recruitment postcode(s) [11]
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3165 - East Bentleigh
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Recruitment postcode(s) [12]
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6009 - Nedlands
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Recruitment postcode(s) [13]
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6000 - Perth
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Iron, one of the most common elements in nature and the most abundant transition metal in the
body, is readily capable of accepting and donating electrons. This capability makes iron a
useful component of various, essential biochemical processes. Despite the essential role of
iron, the excess of iron is toxic to the human body. It is critical for the human body to
maintain iron balance, since humans have no physiologic mechanism for actively removing iron
from the body.
The development of iron overload occurs when iron intake exceeds the body's capacity to
safely store the iron in the liver, which is the primary store for iron. Long-term
transfusion therapy, a life-giving treatment for patients with intractable chronic anemia is
currently the most frequent cause of secondary iron overload.
The mounting evidence regarding the mortality and morbidity due to chronic iron overload in
transfusion dependent anaemias has led to the establishment of guidelines that aim the
improvement of patient outcomes. Further prospective studies are warranted in order to assess
the impact of iron overload in patients with acquired anaemias.
In this study, non-invasive R2- and T2*-MRI techniques were applied to the liver and the
heart, respectively, to complement the primary variable (serum ferritin) assessed in patients
with various transfusion-dependent anaemias. The main objective of this study was to assess
the prevalence and severity of cardiac and liver siderosis in patients with transfusional
siderosis. This study was also aim to establish possible correlations between cardiac and
liver iron levels with clinical effects in patients with different transfusion-dependent
anaemias. Patients were eligible for enrollment irrespective of receiving chelation therapy
or not (and irrespective of the chelating agent used).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01736540
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01736540
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