Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125437
Status:
TERMINATED
Last Update Posted:
2009-07-15
First Post:
2005-07-29
Brief Title:
Larger Dose of Spironolactone for the Treatment of Patients With Nonischemic Cardiomyopathy
Sponsor:
Hebei Medical University
Organization:
Hebei Medical University
Study Overview
Official Title:
Safety and Efficacy of Larger Dose of Spironolactone for the Treatment of Patients With Nonischemic Cardiomyopathy
Status:
TERMINATED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor compliance with the therapy and lot of patients were lost to follow up
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether a larger dose of the aldosterone antagonist spironolactone combined with a lower dose of an ACE inhibitor is more effective in reverse left ventricular remodeling in severe congestive heart failure in patients with nonischemic cardiomyopathy
Detailed Description:
In the investigators recent daily clinical practice they found that the larger dose of the aldosterone antagonist spironolactone combined with a lower dose of an ACE inhibitor and the highest tolerable dose of beta blockers could reverse left ventricular remodeling more effectively than a smaller dose of spironolactone The ventricular remodeling could get back to normal especially in patients with none-ischaemic cardiomyopathy The investigators hypothesize that long term use of a larger dose of the aldosterone antagonist spironolactone could reverse left ventricular remodeling by stimulating new myocyte formation Thus they designed this study to verify its efficacy and safety in reversing left ventricular remodeling in severe congestive heart failure in patients with nonischemic cardiomyopathy To avoid hyperkalemia the investigators routinely use larger doses of diuretics in combination with a lower dose of an ACE inhibitor to offset the potassium-sparing effects of spironolactone and follow the patients closely
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