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Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure

Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01411735
Acronym
PIE-I
Enrollment
71
Registered
2011-08-08
Start date
2003-07-31
Completion date
2008-07-31
Last updated
2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Congestive, Heart Failure With Preserved Ejection Fraction

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.

Interventions

DRUGEnalapril

2.5mg titrated up to 10mg twice daily

DRUGplacebo

2.5mg titrated up to 10mg twice daily.

Sponsors

Wake Forest University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
exercise capacity and aortic distensibility9 monthsMRI and expired gas analysis

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026