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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 3

Conditions

Congestive Heart Failure

Treatments

Drug: Irbesartan

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00095238

CV131-148

Details and patient eligibility

About

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.

Enrollment

4,128 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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.