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

This study has been completed.
Sponsor:
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01411735
First received: August 5, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

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 Intervention Phase
Heart Failure With Preserved Ejection Fraction
Heart Failure, Congestive
Drug: Enalapril
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • exercise capacity and aortic distensibility [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    MRI and expired gas analysis


Enrollment: 71
Study Start Date: July 2003
Study Completion Date: July 2008
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411735

Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Dalane W Kitzman, MD Professor of Medicine-Cardiology Section
  More Information

No publications provided

Responsible Party: Dalane W. Kitzman, MD, Wafe Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01411735     History of Changes
Other Study ID Numbers: RO1 AG18915-01
Study First Received: August 5, 2011
Last Updated: August 5, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases
Enalapril
Enalaprilat
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014