Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure (PIE-I)
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|ClinicalTrials.gov Identifier: NCT01411735|
Recruitment Status : Completed
First Posted : August 8, 2011
Last Update Posted : November 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure With Preserved Ejection Fraction Heart Failure, Congestive||Drug: Enalapril Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||June 2004|
|Actual Study Completion Date :||July 2008|
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.
- exercise capacity and aortic distensibility [ Time Frame: 9 months ]MRI and expired gas analysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411735
|Principal Investigator:||Dalane W Kitzman, MD||Professor of Medicine-Cardiology Section|