Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure

NCT01411735 | Completed Phase 3 DMC

• 1 other identifier: R01AG018915-01
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure With Preserved Ejection Fraction; Heart Failure, Congestive

Outcome Measures

Primary Outcomes (1)

• exercise capacity and aortic distensibility

  MRI and expired gas analysis

  9 months

Study Arms (2)

Enalapril

ACTIVE COMPARATOR

2.5mg titrated up to 10mg- twice daily

Drug: Enalapril

placebo

PLACEBO COMPARATOR

2.5 mg titrate up to 10mg twice daily placebo comparator

Drug: placebo

Interventions

Enalapril DRUG

2.5mg titrated up to 10mg twice daily

Enalapril

placebo DRUG

2.5mg titrated up to 10mg twice daily.

placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants will be 60 years of age or older.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University: lead

MeSH Terms

Conditions

Heart Failure

Interventions

Enalapril

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Dalane W Kitzman, MD

  Professor of Medicine-Cardiology Section

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: August 8, 2011
• Study Start: July 1, 2003
• Primary Completion: June 1, 2004
• Study Completion: July 1, 2008
• Last Updated: November 6, 2017

Record last verified: 2011-08