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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01411735
First Posted: August 8, 2011
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )
August 5, 2011
August 8, 2011
November 6, 2017
July 2003
June 2004   (Final data collection date for primary outcome measure)
exercise capacity and aortic distensibility [ Time Frame: 9 months ]
MRI and expired gas analysis
Same as current
Complete list of historical versions of study NCT01411735 on ClinicalTrials.gov Archive Site
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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.

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Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
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*   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.

Sexes Eligible for Study: All
60 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT01411735
R01AG018915-01( U.S. NIH Grant/Contract )
Yes
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Wake Forest University Health Sciences ( Wake Forest University )
Wake Forest University
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Principal Investigator: Dalane W Kitzman, MD Professor of Medicine-Cardiology Section
Wake Forest University Health Sciences
August 2011

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