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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/NCT00095238
Registration number
NCT00095238
Ethics application status
Date submitted
1/11/2004
Date registered
2/11/2004
Date last updated
7/04/2015
Titles & IDs
Public title
Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)
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Scientific title
Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)
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Secondary ID [1]
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CV131-148
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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:
Congestive Heart Failure
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0
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Condition category
Condition code
Cardiovascular
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0
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Coronary heart disease
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Cardiovascular
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Irbesartan
Treatment: Drugs - Placebo
Active Comparator: 1 -
Placebo Comparator: 2 -
Treatment: Drugs: Irbesartan
Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years
Treatment: Drugs: Placebo
Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years
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Intervention code [1]
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Treatment: Drugs
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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 First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints
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Assessment method [1]
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Treatment comparisons for time to first occurrence of composite outcome of all-cause death (composite outcome of death) or protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include those =24 hrs or involving a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular or atrial dysrhythmia, or stroke, that also require intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. In addition, MI or stroke during any hospitalization are included.
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Timepoint [1]
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Year 1, Year 2, Year 3, Year 4, Year 5
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Secondary outcome [1]
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Percentage of Participants Experiencing Heart Failure Mortality or Heart Failure Hospitalization at Given Time Points
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Assessment method [1]
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Treatment comparisons for time to heart failure mortality or heart failure hospitalization
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Timepoint [1]
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Year 1, Year 2, Year 3, Year 4, Year 5
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Secondary outcome [2]
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Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Month 6 and Month 14
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Assessment method [2]
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Mean score and adjusted mean change from baseline in Minnesota Living with Heart Failure (MLWHF) questionnaire, a 21-item, patient-reported, 6-point (ranging from 0-5; higher score=poorer quality of life; highest possible score=105) measurement of quality of life in persons with heart failure.
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Timepoint [2]
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Baseline, Month 6, Month 14
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Secondary outcome [3]
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Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Final Visit
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Assessment method [3]
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Mean score at baseline and final visit in Minnesota Living with Heart Failure (MLWHF) questionnaire, a 21-item, patient-reported, 6-point (ranging from 0-5; higher score=poorer quality of life; highest possible score=105) measurement of quality of life in persons with heart failure.
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Timepoint [3]
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Baseline, Final Visit=last scheduled visit specified in the protocol at conclusion of the entire study by the sponsor. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
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Secondary outcome [4]
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Change From Baseline in B-Type Natriuretic Peptide (Pro-BNP) at Month 6 and Month 14
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Assessment method [4]
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Adjusted ratio to baseline in geometric mean in Pro-BNP in the blood. Ratio to Baseline = On-therapy geometric mean divided by baseline geometric mean. A lower score signifies improvement. Change from baseline adjusted for baseline value and angiotensin converting enzyme inhibitor use at baseline. Analysis uses natural logarithms of excretion rate values.
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Timepoint [4]
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Baseline, Month 6, Month 14
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Secondary outcome [5]
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Percentage of Participants Experiencing CV Death, Non-Fatal Myocardial Infarction (MI), or Non-Fatal Stroke at Given Timepoints
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Assessment method [5]
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Treatment comparisons for time to cardiovascular death, non-fatal MI, or non-fatal stroke.
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Timepoint [5]
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Year 1, Year 2, Year 3, Year 4, Year 5
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Secondary outcome [6]
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Percentage of Participants Experiencing Cardiovascular Death at Given Timepoints
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Assessment method [6]
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Treatment comparisons for time to cardiovascular death
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Timepoint [6]
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Year 1, Year 2, Year 3, Year 4, Year 5
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Secondary outcome [7]
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Percentage of Participants Experiencing All-cause Death at Given Time Points
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Assessment method [7]
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Treatment comparisons for time to all-cause death
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Timepoint [7]
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Year 1, Year 2, Year 3, Year 4, Year 5
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Secondary outcome [8]
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Change From Baseline in the New York Heart Association (NYHA) Functional Class at Month 6, Month 10, Month 14, and Final Visit
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Assessment method [8]
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NYHA functional classification=4-tiered system relating symptoms to everyday activities & quality of life. (See Reporting Groups for description of each class.) Change of NYHA functional class from baseline was grouped into 3 categories: improved, unchanged, or worsened (based on case report form [CRF] assessment). If a post-randomization CRF assessment was missing or participant died, was hospitalized for worsening heart failure or discontinued study medication for worsening heart failure, the participant was classified as Major Event.
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Timepoint [8]
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Baseline, Month 6, Month 10, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
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Secondary outcome [9]
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Physician Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline
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Assessment method [9]
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This was an assessment of the change in overall physician opinion of change from baseline status. Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.
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Timepoint [9]
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Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
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Secondary outcome [10]
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Participant Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline
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Assessment method [10]
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Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.
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Timepoint [10]
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Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
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Secondary outcome [11]
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Participant Assessment of Fatigue at Month 6, Month 14, and Final Visit Compared With Baseline
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Assessment method [11]
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Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.
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Timepoint [11]
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Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
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Secondary outcome [12]
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Participant Assessment of Dyspnea at Month 6, Month 14, and Final Visit Compared With Baseline
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Assessment method [12]
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Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.
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Timepoint [12]
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Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
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Secondary outcome [13]
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Percentage of Participants Experiencing CV Death or CV Hospitalization at Given Timepoints
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Assessment method [13]
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Treatment comparisons for time to CV death or CV hospitalization. Protocol-specified CV hospitalizations include hospitalizations =24 hrs or involve a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular dysrhythmia, atrial dysrhythmia or stroke that also requires intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. Protocol specified CV hospitalizations also include myocardial infarction or stroke occurring during any hospitalization.
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Timepoint [13]
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Year 1, Year 2, Year 3, Year 4, Year 5
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Secondary outcome [14]
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Percentage of Participants Experiencing Protocol-specified Cardiovascular (CV) Hospitalization at Given Timepoints
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Assessment method [14]
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Treatment comparisons for time to protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include hospitalizations =24 hrs or involve a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular dysrhythmia, atrial dysrhythmia or stroke that also requires intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. Protocol specified CV hospitalizations also include myocardial infarction or stroke occurring during any hospitalization.
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Timepoint [14]
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Year 1, Year 2, Year 3, Year 4, Year 5
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Secondary outcome [15]
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Percentage of Participants With New Onset of Diabetes Among Subjects With No Prior Diabetes History at Given Timepoints
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Assessment method [15]
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Treatment comparisons for time to new onset of diabetes (from adverse event reporting) among subjects with no prior history of diabetes.
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Timepoint [15]
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Year 1, Year 2, Year 3, Year 4, Year 5
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Secondary outcome [16]
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Mean Change From Baseline in Glomerular Filtration Rate (GFR) at Month 6, Month 18, and Month 30
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Assessment method [16]
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Based on the Cockcroft-Gault formula calculation, a commonly used surrogate marker to estimate creatinine clearance, which in turn is an approximate measure of GFR. It employs serum creatinine measurements and a patient's weight to predict the creatinine clearance. Adjusted for baseline GFR and angiotensin-converting enzyme inhibitor use at baseline (ACE-I). A decrease from baseline signifies worsening. The adjusted mean change from baseline value is from the model (calculated prior to rounding), whereas the other two points are the baseline mean and post mean.
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Timepoint [16]
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Baseline, Month 6, Month 18, Month 30
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Secondary outcome [17]
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Mean Change From Baseline in Glomerular Filtration Rate (GFR)at Month 42, Month 54, Month 66
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Assessment method [17]
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Based on the Cockcroft-Gault formula calculation, a commonly used surrogate marker to estimate creatinine clearance, which in turn is an approximate measure of GFR. It employs serum creatinine measurements and a patient's weight to predict the creatinine clearance. Adjusted for baseline GFR and angiotensin-converting enzyme inhibitor use at baseline (ACE-I). A decrease from baseline signifies worsening. The adjusted mean change from baseline value is from the model (calculated prior to rounding), whereas the other two points are the baseline mean and post mean.
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Timepoint [17]
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Baseline, Month 42, Month 54, Month 66
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Secondary outcome [18]
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Number of Participants With New Onset Atrial Fibrillation (AF) Among Those With No Prior AF History or Evidence of AF on Baseline Electrocardiograph (ECG)
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Assessment method [18]
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Frequency of new onset AF in participants with no prior AF history or evidence of AF on baseline ECG. Stratified by use of angiotensin-converting enzyme (ACE) inhibitors and measured by adverse events reporting and final ECG recording read by the investigator.
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Timepoint [18]
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Baseline, Final Visit
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Eligibility
Key inclusion criteria
- Male or female age >= 60 years with current symptoms of heart failure consistent with
New York Heart Association (NYHA) class II-IV
- Left ventricular ejection fraction (LVEF) > = 45%
- Willing to provide written informed consent AND hospitalization for heart failure
within the past 6 months OR various abnormalities in electrocardiogram, echocardiogram
or chest x-ray indicating heart disease.
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Minimum age
60
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
- Acute myocardial infarction within 3 months;
- Heart revascularization procedure within 3 months;
- Hospitalization for angina within 3 months;
- Other heart surgery
- Life-threatening or uncontrolled arrhythmia
- Subjects with an implantable cardioverter-defibrillator that has discharged in the
past 3 months;
- Stroke or surgery of the arteries in the brain within 3 months;
- Serious lung disease which requires use of home oxygen.
- Significantly low blood pressure
- Significantly high blood pressure
- Other known diseases that may limit life expectancy to <3 years;
- Known or suspected bilateral kidney artery narrowing;
- Geographic or social factors making study participation and follow-up impractical.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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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
1/06/2002
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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
1/07/2008
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Sample size
Target
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Accrual to date
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Final
4128
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
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Recruitment hospital [1]
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Local Institution - Coffs Harbour
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Recruitment hospital [2]
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Local Institution - Concord
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Recruitment hospital [3]
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Local Institution - Garran
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Recruitment hospital [4]
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Local Institution - Kogarah
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Recruitment hospital [5]
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Local Institution - Randwick
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Recruitment hospital [6]
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Local Institution - Auchenflower
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Recruitment hospital [7]
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Local Institution - Brisbane
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Recruitment hospital [8]
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Local Institution - Woolloongabba
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Recruitment hospital [9]
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Local Institution - Launceston
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Recruitment hospital [10]
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Local Institution - Geelong
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Recruitment hospital [11]
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Local Institution - Prahran
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Recruitment postcode(s) [1]
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- Coffs Harbour
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Recruitment postcode(s) [2]
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- Concord
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Recruitment postcode(s) [3]
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- Garran
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Recruitment postcode(s) [4]
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- Kogarah
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Recruitment postcode(s) [5]
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- Randwick
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Recruitment postcode(s) [6]
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- Auchenflower
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Recruitment postcode(s) [7]
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- Brisbane
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Recruitment postcode(s) [8]
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- Woolloongabba
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Recruitment postcode(s) [9]
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- Launceston
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Recruitment postcode(s) [10]
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- Geelong
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Recruitment postcode(s) [11]
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- Prahran
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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Arizona
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Arkansas
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California
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United States of America
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Connecticut
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Florida
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Illinois
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Indiana
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State/province [9]
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Kentucky
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United States of America
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State/province [10]
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Louisiana
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Maine
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Maryland
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Massachusetts
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Minnesota
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Missouri
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Argentina
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Cordoba
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Argentina
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Corrientes
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Argentina
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Mendoza
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Belgium
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Aalst
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AYE
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Borgerhout
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Belgium
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Genk-waterschei
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Belgium
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Gent
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Hasselt
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Belgium
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HUY
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Belgium
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Leuven
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Belgium
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Verviers
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Brazil
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Bahia
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Brazil
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Goias
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Brazil
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Minas Gerais
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Brazil
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Sao Paulo
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Brazil
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Rio de Janeiro
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Prague 2
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Czech Republic
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Prague 4
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Czech Republic
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Prague 9
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Czech Republic
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Usti Nad Labem
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0
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Denmark
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Copenhagen Nv
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Denmark
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Copenhagen
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France
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Abbeville
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France
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State/province [63]
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Cholet
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Country [64]
0
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France
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State/province [64]
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DAX
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Country [65]
0
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France
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GAP
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0
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France
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Langres
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Country [67]
0
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France
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Lille
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0
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France
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Montbeliard
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Country [69]
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France
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Paris Cedex 13
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France
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Poissy
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France
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Pontoise
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France
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Provins
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France
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Roubaix
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France
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France
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Saint Malo
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France
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Tours
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France
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Vandoeuvre Les Nancy
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France
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Vichy Cedex
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Germany
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Bad Homburg
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Germany
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Berlin
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Germany
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Goettingen
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Germany
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Gunzenhausen
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Germany
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Halle
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Germany
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Homburg / Saar
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Germany
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Jena
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Germany
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Langen
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Germany
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Leipzig
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Germany
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Mainz
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Germany
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Marburg
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Germany
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Muenchen
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Germany
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Regensburg
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Germany
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Stuttgart
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Germany
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Witten
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Germany
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Wuerzburg
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Greece
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Greece
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Patras
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Hungary
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Hungary
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Italy
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Ascoli Piceno
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Italy
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Italy
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Italy
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Cosenza
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Italy
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Pavia
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Italy
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Italy
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Piacenza
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Italy
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Roma
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Italy
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Siena
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Italy
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Trieste
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Italy
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Udine
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Mexico
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Distrito Federal
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Mexico
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Mexico
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Mexico
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Amersfoort
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Rotterdam
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Zaandam
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Norway
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Tonsberg
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Portugal
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Portugal
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Matosinhos
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Moscow
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St. Petersburg
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South Africa
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Gauteng
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Madrid
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United Kingdom
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Londonderry
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Sanofi
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Ethics approval
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Summary
Brief summary
The purpose of this clinical research study is to learn if Irbesartan is superior to placebo
in reducing mortality and cardiovascular morbidity in subjects with heart failure with
preserved systolic function. The safety of this treatment will also be studied.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00095238
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00095238
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