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PIE II: Pharmacological Intervention in the Elderly II

NCT00123955 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-02-27

Study results available
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Summary

The purpose of this study is to examine whether spironolactone will improve exercise tolerance and quality of life in elderly patients with heart failure preserved ejection fraction (HFPEF).

Conditions

  • Diastolic Heart Failure
  • Heart Failure, Congestive

Interventions

DRUG

Spironolactone

25mg tablet daily for 9 months

DRUG

Placebo

Placebo tablet daily for 9 months

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Wake Forest University

    lead OTHER

Principal Investigators

  • Dalane W. Kitzman, MD · Professor of Internal Medicine, Cardiology, Director of Echocardiography, Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2009-06-30
Completion
2012-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00123955 on ClinicalTrials.gov