Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure

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.

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Key information

Conditions

Heart Failure With Preserved Ejection Fraction Cardiovascular Diseases Heart Diseases Heart Failure Heart Failure, Congestive

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All participants will be 60 years of age or older.

Exclusion criteria

systolic dysfunction
patients with evidence of significant ischemic or valvular heart disease
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.

Treatment and study plan

Enalapril

Drug

2.5mg titrated up to 10mg twice daily

Placebo

Drug

2.5mg titrated up to 10mg twice daily.

Primary outcomes

exercise capacity and aortic distensibility

Time frame: 9 months

MRI and expired gas analysis

Sponsors and collaborators

Lead sponsor

Wake Forest University

Other

Registry information

Acronym: PIE-I

Important dates

Study start: 2003
Primary completion: 2004
Study completion: 2008
First posted: Aug 8, 2011
Registry last updated: Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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