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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2008

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

• Time from randomization to the first occurence of the composite outcome of death (all cause) or cardiovascular hospitalization
  • Time Frame: Time from randomization to the first occurence
    

Secondary Measures

• Cardiovascular death analyzed
  • Time Frame: as time to event
    
• All cause mortality analyzed
  • Time Frame: as time to event
    
• Combined vascular endpoint: cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke analyzed
  • Time Frame: as time to first event
    
• Combined heart
  • Time Frame: as time to event
    

Inclusion Criteria:

• Male or female of Age >= 60 years with heart failure with preserved systolic function of the heart.
• 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 Sponsor: Bristol-Myers Squibb

Overall Clinical Trial Officials and Contacts

Bristol-Myers Squibb Study Director Bristol-Myers Squibb  

Information obtained from ClinicalTrials.gov on August 28, 2008

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