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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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)
Scientific title
Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)
Secondary ID [1] 0 0
CV131-148
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congestive Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints - 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.
Timepoint [1] 0 0
Year 1, Year 2, Year 3, Year 4, Year 5
Secondary outcome [1] 0 0
Percentage of Participants Experiencing Heart Failure Mortality or Heart Failure Hospitalization at Given Time Points - Treatment comparisons for time to heart failure mortality or heart failure hospitalization
Timepoint [1] 0 0
Year 1, Year 2, Year 3, Year 4, Year 5
Secondary outcome [2] 0 0
Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Month 6 and Month 14 - 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.
Timepoint [2] 0 0
Baseline, Month 6, Month 14
Secondary outcome [3] 0 0
Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Final Visit - 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.
Timepoint [3] 0 0
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.
Secondary outcome [4] 0 0
Change From Baseline in B-Type Natriuretic Peptide (Pro-BNP) at Month 6 and Month 14 - 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.
Timepoint [4] 0 0
Baseline, Month 6, Month 14
Secondary outcome [5] 0 0
Percentage of Participants Experiencing CV Death, Non-Fatal Myocardial Infarction (MI), or Non-Fatal Stroke at Given Timepoints - Treatment comparisons for time to cardiovascular death, non-fatal MI, or non-fatal stroke.
Timepoint [5] 0 0
Year 1, Year 2, Year 3, Year 4, Year 5
Secondary outcome [6] 0 0
Percentage of Participants Experiencing Cardiovascular Death at Given Timepoints - Treatment comparisons for time to cardiovascular death
Timepoint [6] 0 0
Year 1, Year 2, Year 3, Year 4, Year 5
Secondary outcome [7] 0 0
Percentage of Participants Experiencing All-cause Death at Given Time Points - Treatment comparisons for time to all-cause death
Timepoint [7] 0 0
Year 1, Year 2, Year 3, Year 4, Year 5
Secondary outcome [8] 0 0
Change From Baseline in the New York Heart Association (NYHA) Functional Class at Month 6, Month 10, Month 14, and Final Visit - 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.
Timepoint [8] 0 0
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.
Secondary outcome [9] 0 0
Physician Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline - 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.
Timepoint [9] 0 0
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.
Secondary outcome [10] 0 0
Participant Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline - 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.
Timepoint [10] 0 0
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.
Secondary outcome [11] 0 0
Participant Assessment of Fatigue at Month 6, Month 14, and Final Visit Compared With Baseline - 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.
Timepoint [11] 0 0
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.
Secondary outcome [12] 0 0
Participant Assessment of Dyspnea at Month 6, Month 14, and Final Visit Compared With Baseline - 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.
Timepoint [12] 0 0
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.
Secondary outcome [13] 0 0
Percentage of Participants Experiencing CV Death or CV Hospitalization at Given Timepoints - 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.
Timepoint [13] 0 0
Year 1, Year 2, Year 3, Year 4, Year 5
Secondary outcome [14] 0 0
Percentage of Participants Experiencing Protocol-specified Cardiovascular (CV) Hospitalization at Given Timepoints - 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.
Timepoint [14] 0 0
Year 1, Year 2, Year 3, Year 4, Year 5
Secondary outcome [15] 0 0
Percentage of Participants With New Onset of Diabetes Among Subjects With No Prior Diabetes History at Given Timepoints - Treatment comparisons for time to new onset of diabetes (from adverse event reporting) among subjects with no prior history of diabetes.
Timepoint [15] 0 0
Year 1, Year 2, Year 3, Year 4, Year 5
Secondary outcome [16] 0 0
Mean Change From Baseline in Glomerular Filtration Rate (GFR) at Month 6, Month 18, and Month 30 - 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.
Timepoint [16] 0 0
Baseline, Month 6, Month 18, Month 30
Secondary outcome [17] 0 0
Mean Change From Baseline in Glomerular Filtration Rate (GFR)at Month 42, Month 54, Month 66 - 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.
Timepoint [17] 0 0
Baseline, Month 42, Month 54, Month 66
Secondary outcome [18] 0 0
Number of Participants With New Onset Atrial Fibrillation (AF) Among Those With No Prior AF History or Evidence of AF on Baseline Electrocardiograph (ECG) - 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.
Timepoint [18] 0 0
Baseline, Final Visit

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.
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 0 0
Local Institution - Coffs Harbour
Recruitment hospital [2] 0 0
Local Institution - Concord
Recruitment hospital [3] 0 0
Local Institution - Garran
Recruitment hospital [4] 0 0
Local Institution - Kogarah
Recruitment hospital [5] 0 0
Local Institution - Randwick
Recruitment hospital [6] 0 0
Local Institution - Auchenflower
Recruitment hospital [7] 0 0
Local Institution - Brisbane
Recruitment hospital [8] 0 0
Local Institution - Woolloongabba
Recruitment hospital [9] 0 0
Local Institution - Launceston
Recruitment hospital [10] 0 0
Local Institution - Geelong
Recruitment hospital [11] 0 0
Local Institution - Prahran
Recruitment postcode(s) [1] 0 0
- Coffs Harbour
Recruitment postcode(s) [2] 0 0
- Concord
Recruitment postcode(s) [3] 0 0
- Garran
Recruitment postcode(s) [4] 0 0
- Kogarah
Recruitment postcode(s) [5] 0 0
- Randwick
Recruitment postcode(s) [6] 0 0
- Auchenflower
Recruitment postcode(s) [7] 0 0
- Brisbane
Recruitment postcode(s) [8] 0 0
- Woolloongabba
Recruitment postcode(s) [9] 0 0
- Launceston
Recruitment postcode(s) [10] 0 0
- Geelong
Recruitment postcode(s) [11] 0 0
- Prahran
Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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Arizona
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United States of America
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Arkansas
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Indiana
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Nijmegen
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Rotterdam
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Sittard
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Sneek
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Veldhoven
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Vlaardingen
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Zaandam
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Norway
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Baerum Postterminal
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Norway
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Stavanger
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Norway
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Tonsberg
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Bydgoszcz
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Katowice
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Piotrkow Tryb.
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Stalowa Wola
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Warszawa
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Wroclaw
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Portugal
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Lisbon
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Matosinhos
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Russian Federation
State/province [148] 0 0
Moscow
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Madrid
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Sevilla
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State/province [161] 0 0
Valencia
Country [162] 0 0
Spain
State/province [162] 0 0
Zaragoza
Country [163] 0 0
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State/province [163] 0 0
Falun
Country [164] 0 0
Sweden
State/province [164] 0 0
Gothenburg
Country [165] 0 0
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State/province [166] 0 0
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Sweden
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Liestal
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Essex
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Yorkshire
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Dundee
Country [177] 0 0
United Kingdom
State/province [177] 0 0
Londonderry

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Sanofi
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00095238
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications