Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00293137
Status:
TERMINATED
Last Update Posted:
2008-09-19
First Post:
2006-02-16
Brief Title:
NORDIC Nitric Oxide-Derived Oxidants and Regional Endothelial and Diastolic Dysfunction in Dilated Cardiomyopathy
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Nitric Oxide-Derived Oxidants and Regional Endothelial and Diastolic Dysfunction in Dilated Cardiomyopathy
Status:
TERMINATED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
safety concerns regarding use of rosiglitazone
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NORDIC
Brief Summary:
The principal aim is to investigate the safety and efficacy of rosiglitazone in patients with chronic systolic heart Dilated cardiomyopathy We hypothesize that in patients with heart failure rosiglitazone is safe and can reduce nitric oxide NO derived oxidative stress in particular nitrotyrosine thereby improving endothelial dysfunction left ventricular performance and metabolic parameters
Detailed Description:
The study will be a single center double-blind prospective placebo controlled trial of 60 non-diabetic heart failure patients Prior to administration of study medication a medical history physician exam blood draw laser Doppler imaging Periscan system venous occlusion strain gauge plethysmography metabolic exercise stress test and 2D and 3D echocardiograms will be performed Patients will then be randomized to receive rosiglitazone 2mgday oral versus placebo with up-titration to 4mgday oral versus placebo at 3 months Each study arm will have 30 patients who will participate for 6 months Follow up assessments will be completed at 6 weeks 3 months and 6 months post randomization
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