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

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Sanofi
• Treatments: Irbesartan

Criteria

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.