Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure

Phase 3

Completed

• Conditions: Heart Failure, Congestive; Heart Failure With Preserved Ejection Fraction
• Interventions: Drug: placebo; Drug: Enalapril

• Registration Number: NCT01411735
• Lead Sponsor: Wake Forest University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Primary Completion: 2004-06
• Study Completion: 2008-07
• Status Verified: 2011-08
• Study First Submitted: 2011-08-05
• Study First Submitted QC: 2011-08-05
• Study First Posted: 2011-08-08
• Last Update Submitted: 2017-11-01
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• All participants will be 60 years of age or older.

Exclusion Criteria

1. systolic dysfunction
2. patients with evidence of significant ischemic or valvular heart disease
3. chronic pulmonary disease.

Participants who appear preliminarily eligible are invited to a formal screening visiting with an investigator cardiology physician. They also undergoing a rest and exercise electrocardiogram and echocardiogram and pulmonary function testing as well as blood hematology and chemistry tests.

Final eligibility will be based upon all information available at the conclusion of the screening visits test, including hospital and outpatient records, history, physical examination, echocardiogram and exercise test.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	2.5 mg titrate up to 10mg twice daily placebo comparator
Enalapril	Enalapril	2.5mg titrated up to 10mg- twice daily

Primary Outcome Measures

Name	Time	Method
exercise capacity and aortic distensibility	9 months	MRI and expired gas analysis