Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00108251
Status:
COMPLETED
Last Update Posted:
2011-09-08
First Post:
2005-04-14
Brief Title:
Aldosterone Antagonism in Diastolic Heart Failure
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Aldosterone Antagonism in Diastolic Heart Failure
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 11 ratio to 1 Placebo n24 or to 2 Eplerenone n24 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 BNPand change in quality of life
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 11 ratio to 1 Placebo n24 or to 2 Eplerenone n24 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 BNPand change in quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None