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

Primary Purpose

Heart Failure With Preserved Ejection Fraction, Heart Failure, Congestive

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Enalapril
placebo
Sponsored by
Wake Forest University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Enalapril

    placebo

    Arm Description

    2.5mg titrated up to 10mg- twice daily

    2.5 mg titrate up to 10mg twice daily placebo comparator

    Outcomes

    Primary Outcome Measures

    exercise capacity and aortic distensibility
    MRI and expired gas analysis

    Secondary Outcome Measures

    Full Information

    First Posted
    August 5, 2011
    Last Updated
    November 1, 2017
    Sponsor
    Wake Forest University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01411735
    Brief Title
    Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure
    Acronym
    PIE-I
    Official Title
    Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2003 (undefined)
    Primary Completion Date
    June 2004 (Actual)
    Study Completion Date
    July 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wake Forest University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure With Preserved Ejection Fraction, Heart Failure, Congestive

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    71 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Enalapril
    Arm Type
    Active Comparator
    Arm Description
    2.5mg titrated up to 10mg- twice daily
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    2.5 mg titrate up to 10mg twice daily placebo comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Enalapril
    Intervention Description
    2.5mg titrated up to 10mg twice daily
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    2.5mg titrated up to 10mg twice daily.
    Primary Outcome Measure Information:
    Title
    exercise capacity and aortic distensibility
    Description
    MRI and expired gas analysis
    Time Frame
    9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All participants will be 60 years of age or older. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dalane W Kitzman, MD
    Organizational Affiliation
    Professor of Medicine-Cardiology Section
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure

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