NCT00123955

PIE II: Pharmacological Intervention in the Elderly II

Exercise Intolerance in Elderly Diastolic Heart Failure

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Wake Forest University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Exercise intolerance due to HFPEF is a major cause of disability among older Americans. Several lines of evidence suggest that aldosterone antagonism may improve exercise tolerance in HFPEF. Therefore, the primary aim of this study is to test the hypothesis that spironolactone will improve exercise tolerance and quality of life in elderly patients with isolated HFPEF. A total of 72 participants aged 60 or older will be randomized to receive either spironolactone 25mg daily or a placebo.

Conditions

• Diastolic Heart Failure
• Heart Failure, Congestive

Interventions

Type	Name	Description
DRUG	Spironolactone	25mg tablet daily for 9 months
DRUG	Placebo	Placebo tablet daily for 9 months

Timeline

• Start date: 2005-04-01
• Primary completion: 2009-06-01
• Completion: 2012-12-01
• First posted: 2005-07-26
• Last updated: 2019-02-27
• Results posted: 2015-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study