Aldosterone Antagonism in Diastolic Heart Failure
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.
Congestive Heart Failure
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Aldosterone Antagonism in Diastolic Heart Failure|
- Change in Six Minute Walk Distance from baseline to 24 weeks after randomization [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]change in six minute walk distance between the placebo and spironolactone group
- Change in left ventricular stiffness at 24 weeks, Change in other echocardiographic measures of diastolic dysfunction at 24 weeks, Change in levels of B-type natriuretic peptide (BNP) at 24 weeks; Change in quality of life at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]change in above echocardiogtraphic measures between placebo and spironolactone group
|Study Start Date:||August 2004|
|Study Completion Date:||October 2007|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
Placebo Comparator: 1
aldosterone receptor blocker
Other Name: Inspra
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00108251
|United States, Texas|
|Michael E DeBakey VA Medical Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Anita Deswal, MD MPH MBBS||Michael E DeBakey VA Medical Center|