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.

Study Overview

• Status: Completed
• Conditions: Heart Failure, Congestive; Heart Failure With Preserved Ejection Fraction
• Intervention / Treatment: Drug: Enalapril; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Enalapril; 2.5mg titrated up to 10mg- twice daily	Drug: Enalapril; 2.5mg titrated up to 10mg twice daily
PLACEBO_COMPARATOR: placebo; 2.5 mg titrate up to 10mg twice daily placebo comparator	Drug: placebo; 2.5mg titrated up to 10mg twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
exercise capacity and aortic distensibility	MRI and expired gas analysis	9 months

Collaborators and Investigators

• Sponsor: Wake Forest University
• Investigators: Principal Investigator: Dalane W Kitzman, MD, Professor of Medicine-Cardiology Section

Study record dates

Study Major Dates

• Study Start: July 1, 2003
• Primary Completion (ACTUAL): June 1, 2004
• Study Completion (ACTUAL): July 1, 2008

Study Registration Dates

• First Submitted: August 5, 2011
• First Submitted That Met QC Criteria: August 5, 2011
• First Posted (ESTIMATE): August 8, 2011

Study Record Updates

• Last Update Posted (ACTUAL): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 1, 2017
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Heart Failure, Diastolic; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Angiotensin-Converting Enzyme Inhibitors; Enalapril
• Other Study ID Numbers: R01AG018915-01 (NIH)