Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure

Heart Failure, Congestive Clinical Trial

— PIE-I  

Official title:

Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01411735
• Other study ID #: R01AG018915-01
• Status: Completed
• Phase: Phase 3
• First received: August 5, 2011
• Last updated: November 1, 2017
• Start date: July 2003
• Est. completion date: July 2008

Study information

• Verified date: August 2011
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: July 2008
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction
• Heart Failure, Congestive
• Heart Failure, Diastolic

Intervention

Drug:
• Enalapril
2.5mg titrated up to 10mg twice daily
• placebo
2.5mg titrated up to 10mg twice daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	exercise capacity and aortic distensibility	MRI and expired gas analysis	9 months