PIE-I: Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure

Sponsor

Wake Forest University (Other)

Overall Status

Completed

CT.gov ID

NCT01411735

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure With Preserved Ejection Fraction Heart Failure, Congestive	Drug: Enalapril Drug: placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

71 participants

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

Study Start Date :

Jul 1, 2003

Actual Primary Completion Date :

Jun 1, 2004

Actual Study Completion Date :

Jul 1, 2008

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

exercise capacity and aortic distensibility [9 months]
MRI and expired gas analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Wake Forest University

Investigators

Principal Investigator: Dalane W Kitzman, MD, Professor of Medicine-Cardiology Section

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wake Forest University

ClinicalTrials.gov Identifier:

NCT01411735

Other Study ID Numbers:

R01AG018915-01

First Posted:

Aug 8, 2011

Last Update Posted:

Nov 6, 2017

Last Verified:

Aug 1, 2011

Additional relevant MeSH terms:

Heart Failure

Heart Failure, Diastolic

Enalapril

Study Results

No Results Posted as of Nov 6, 2017