Status:
COMPLETED
Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Sanofi
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief 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 f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
4128 Patients enrolled
Trial Details
Trial ID
NCT00095238
Start Date
June 1 2002
End Date
July 1 2008
Last Update
April 7 2015
Active Locations (229)
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1
Local Institution
Birmingham, Alabama, United States
2
Local Institution
Peoria, Arizona, United States
3
Local Institution
Tucson, Arizona, United States
4
Local Institution
Little Rock, Arkansas, United States