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

August 5, 2011
August 5, 2011
July 2003
June 2004   (final data collection date for primary outcome measure)
exercise capacity and aortic distensibility [ Time Frame: 9 months ] [ Designated as safety issue: No ]
MRI and expired gas analysis
Same as current
No Changes Posted
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Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure
Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Heart Failure With Preserved Ejection Fraction
  • Heart Failure, Congestive
  • Drug: Enalapril
    2.5mg titrated up to 10mg twice daily
  • Drug: placebo
    2.5mg titrated up to 10mg twice daily.
  • Active Comparator: Enalapril
    2.5mg titrated up to 10mg- twice daily
    Intervention: Drug: Enalapril
  • Placebo Comparator: placebo
    2.5 mg titrate up to 10mg twice daily placebo comparator
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
July 2008
June 2004   (final data collection date for primary outcome measure)

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.

Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01411735
RO1 AG18915-01
Yes
Dalane W. Kitzman, MD, Wafe Forest University Health Sciences
Wake Forest School of Medicine
Not Provided
Principal Investigator: Dalane W Kitzman, MD Professor of Medicine-Cardiology Section
Wake Forest School of Medicine
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP