NCT00108251

Aldosterone Antagonism in Diastolic Heart Failure

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: US Department of Veterans Affairs · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to determine whether eplerenone has a beneficial effect on improving exercise ability in patients with diastolic heart failure.

Detailed description

The objectives of this study are: 1) To evaluate the effect of eplerenone, an aldosterone antagonist, on intermediate functional outcomes in patients with DHF (diastolic heart failure); 2) To evaluate the effect of eplerenone, an aldosterone antagonist, on echocardiographic measures of diastolic dysfunction in patients with DHF. The study is an double-blind, placebo-controlled study evaluating the effects of eplerenone compared to placebo in patients with DHF. A total of 48 patients with DHF will be randomized in a 1:1 ratio to 1) Placebo (n=24) or to 2) Eplerenone (n=24) in a dose of 25 mg a day for the first 2 weeks followed by uptitration to 50 mg a day for 22 weeks. The primary outcome is an improvement in functional capacity, measured by the distance covered in a 6-minute walk test. Secondary Outcomes include : Change echocardiographic measures of diastolic dysfunction, change in levels of B-type natriuretic peptide (BNP)and change in quality of life.

Conditions

• Congestive Heart Failure
• Diastole

Interventions

Type	Name	Description
DRUG	Eplerenone	aldosterone receptor blocker
DRUG	Placebo	matching placebo

Timeline

• Start date: 2004-08-01
• Primary completion: 2007-09-01
• Completion: 2007-10-01
• First posted: 2005-04-15
• Last updated: 2011-09-08

Locations

1 site across 1 country: United States