NORDIC: Nitric Oxide-Derived Oxidants and Regional Endothelial and Diastolic Dysfunction in Dilated Cardiomyopathy
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.
|Official Title:||Nitric Oxide-Derived Oxidants and Regional Endothelial and Diastolic Dysfunction in Dilated Cardiomyopathy|
- Primary Endpoint • Comparison of NO-derived oxidants, systemic ADMA, skin blood flow, forearm blood flow and exhaled NO. • Correlation of NO-derived oxidants, systemic ADMA, skin blood flow, forearm blood flow and exhaled NO to functional capacity [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
|Study Start Date:||February 2006|
|Study Completion Date:||August 2007|
Patients enrolled into the trial must have left ventricular ejection fraction of <40% by echocardiogram within 6 months of enrollment
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 2mg/day oral versus placebo with up-titration to 4mg/day 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00293137
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Wilson H Tang, M.D.||The Cleveland Clinic|