This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Wake Forest University Health Sciences Identifier:
First received: August 5, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted

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
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

Resource links provided by NLM:

Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • exercise capacity and aortic distensibility [ Time Frame: 9 months ]
    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.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01411735

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

Responsible Party: Dalane W. Kitzman, MD, Wafe Forest University Health Sciences Identifier: NCT01411735     History of Changes
Other Study ID Numbers: R01AG018915-01 ( U.S. NIH Grant/Contract )
Study First Received: August 5, 2011
Last Updated: August 5, 2011

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents processed this record on August 23, 2017