Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure (PIE-I)
BACKGROUND: Exercise intolerance is the primary symptom in older patients with heart failure and preserved ejection fraction (HFPEF), however little is known regarding its mechanisms and therapy.
METHODS: 71 elderly stable, compensated HFPEF patients (age 70+1 years; 80% women) with controlled blood pressure were randomized into a 12 month follow-up (FU) double-blind trial of enalapril 20 mg per day (E) vs. placebo (P). Assessments included: peak exercise oxygen consumption (VO2); six-minute walk test; Minnesota Living with HF Questionnaire (MLHF); MRI; Doppler-echocardiography; and vascular ultrasound.
|Heart Failure With Preserved Ejection Fraction Heart Failure, Congestive||Drug: Enalapril Drug: placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure|
- exercise capacity and aortic distensibility [ Time Frame: 9 months ]MRI and expired gas analysis
|Study Start Date:||July 2003|
|Study Completion Date:||July 2008|
|Primary Completion Date:||June 2004 (Final data collection date for primary outcome measure)|
Active Comparator: Enalapril
2.5mg titrated up to 10mg- twice daily
2.5mg titrated up to 10mg twice daily
Placebo Comparator: placebo
2.5 mg titrate up to 10mg twice daily placebo comparator
2.5mg titrated up to 10mg twice daily.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411735
|Principal Investigator:||Dalane W Kitzman, MD||Professor of Medicine-Cardiology Section|