Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)

Official Title: “Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)”

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.

Intervention(s) in this Clinical Trial

• Drug: Irbesartan
  • Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years
• Drug: Placebo
  • Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Placebo Comparator: 2

Primary Measures

• Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints
  • Time Frame: Year 1, Year 2, Year 3, Year 4, Year 5
    Safety Issue?: No

Secondary Measures

• Percentage of Participants Experiencing Heart Failure Mortality or Heart Failure Hospitalization at Given Time Points
  • Time Frame: Year 1, Year 2, Year 3, Year 4, Year 5
    Safety Issue?: No
• Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Month 6 and Month 14
  • Time Frame: Baseline, Month 6, Month 14
    Safety Issue?: No
• Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Final Visit
  • Time Frame: 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.
    Safety Issue?: No
• Change From Baseline in B-Type Natriuretic Peptide (Pro-BNP) at Month 6 and Month 14
  • Time Frame: Baseline, Month 6, Month 14
    Safety Issue?: Yes
• Percentage of Participants Experiencing CV Death, Non-Fatal Myocardial Infarction (MI), or Non-Fatal Stroke at Given Timepoints
  • Time Frame: Year 1, Year 2, Year 3, Year 4, Year 5
    Safety Issue?: No
• Percentage of Participants Experiencing Cardiovascular Death at Given Timepoints
  • Time Frame: Year 1, Year 2, Year 3, Year 4, Year 5
    Safety Issue?: No
• Percentage of Participants Experiencing All-cause Death at Given Time Points
  • Time Frame: Year 1, Year 2, Year 3, Year 4, Year 5
    Safety Issue?: No
• Change From Baseline in the New York Heart Association (NYHA) Functional Class at Month 6, Month 10, Month 14, and Final Visit
  • Time Frame: 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.
    Safety Issue?: No
• Physician Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline
  • Time Frame: 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.
    Safety Issue?: No
• Participant Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline
  • Time Frame: 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.
    Safety Issue?: No
• Participant Assessment of Fatigue at Month 6, Month 14, and Final Visit Compared With Baseline
  • Time Frame: 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.
    Safety Issue?: No
• Participant Assessment of Dyspnea at Month 6, Month 14, and Final Visit Compared With Baseline
  • Time Frame: 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.
    Safety Issue?: No
• Percentage of Participants Experiencing CV Death or CV Hospitalization at Given Timepoints
  • Time Frame: Year 1, Year 2, Year 3, Year 4, Year 5
    Safety Issue?: No
• Percentage of Participants Experiencing Protocol-specified Cardiovascular (CV) Hospitalization at Given Timepoints
  • Time Frame: Year 1, Year 2, Year 3, Year 4, Year 5
    Safety Issue?: No
• Percentage of Participants With New Onset of Diabetes Among Subjects With No Prior Diabetes History at Given Timepoints
  • Time Frame: Year 1, Year 2, Year 3, Year 4, Year 5
    Safety Issue?: Yes
• Mean Change From Baseline in Glomerular Filtration Rate (GFR) at Month 6, Month 18, and Month 30
  • Time Frame: Baseline, Month 6, Month 18, Month 30
    Safety Issue?: No
• Mean Change From Baseline in Glomerular Filtration Rate (GFR)at Month 42, Month 54, Month 66
  • Time Frame: Baseline, Month 42, Month 54, Month 66
    Safety Issue?: No
• Number of Participants With New Onset Atrial Fibrillation (AF) Among Those With No Prior AF History or Evidence of AF on Baseline Electrocardiograph (ECG)
  • Time Frame: Baseline, Final Visit
    Safety Issue?: No

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.

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Bristol-Myers Squibb Industry

Overall Clinical Trial Officials and Contacts

Bristol-Myers Squibb Study Director Bristol-Myers Squibb  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00095238

Study ID Number: CV131-148

ClinicalTrials.gov Identifier: NCT00095238

Health Authority: United States: Food and Drug Administration

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm