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

• ClinicalTrials.gov Identifier: NCT01411735
• Recruitment Status: Completed
• First Posted: August 8, 2011
• Last Update Posted: November 6, 2017
• Sponsor: Wake Forest University
• Information provided by (Responsible Party): Wake Forest University Health Sciences ( Wake Forest University )

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 (Clinical Trial)
• 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: July 2003
• Actual Primary Completion Date: June 2004
• Actual Study Completion Date: July 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.

Outcome Measures

Primary Outcome Measures :

1. exercise capacity and aortic distensibility [ Time Frame: 9 months ]
   MRI and expired gas analysis

Eligibility Criteria

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

Wake Forest University

Investigators

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

More Information

• Responsible Party: Wake Forest University
• ClinicalTrials.gov Identifier: NCT01411735
• Other Study ID Numbers: R01AG018915-01 ( U.S. NIH Grant/Contract )
• First Posted: August 8, 2011
• Last Update Posted: November 6, 2017
• Last Verified: August 2011

Additional relevant MeSH terms:

Heart Failure; Heart Failure, Diastolic; Heart Diseases; Cardiovascular Diseases; Enalapril; Angiotensin-Converting Enzyme Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents