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

Completed · Phase 3 · Has a placebo group

Conditions studied: Congestive Heart Failure

In brief

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.

Key facts

Study ID

NCT00095238

Run by

Bristol-Myers Squibb

People needed

4128

Starts

2002-06-01

Expected to finish

2008-07-01

Last updated by the study team

2015-04-07

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Local Institution — Peoria, Arizona, United States
• Local Institution — Tucson, Arizona, United States
• Local Institution — Little Rock, Arkansas, United States
• Local Institution — Los Angeles, California, United States
• Local Institution — San Diego, California, United States
• Local Institution — San Francisco, California, United States
• Local Institution — Farmington, Connecticut, United States
• Local Institution — Jacksonville, Florida, United States
• Local Institution — Jacksonville Beach, Florida, United States
• Local Institution — Lake Worth, Florida, United States
• Local Institution — Tampa, Florida, United States
• Local Institution — Vero Beach, Florida, United States
• Local Institution — Chicago, Illinois, United States
• Local Institution — Peoria, Illinois, United States
• Local Institution — Jeffersonville, Indiana, United States
• Local Institution — Louisville, Kentucky, United States
• Local Institution — Chalmette, Louisiana, United States
• Local Institution — Shreveport, Louisiana, United States
• Local Institution — Auburn, Maine, United States
• Local Institution — Takoma Park, Maryland, United States
• Local Institution — Towson, Maryland, United States
• Local Institution — Boston, Massachusetts, United States
• Local Institution — Haverhill, Massachusetts, United States
• Local Institution — Natick, Massachusetts, United States
• Local Institution — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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