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Sponsored by: |
The Cleveland Clinic |
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Information provided by: | The Cleveland Clinic |
ClinicalTrials.gov Identifier: | NCT00293137 |
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.
Study Type: | Observational |
Official Title: | Nitric Oxide-Derived Oxidants and Regional Endothelial and Diastolic Dysfunction in Dilated Cardiomyopathy |
Estimated Enrollment: | 60 |
Study Start Date: | February 2006 |
Study Completion Date: | August 2007 |
Groups/Cohorts |
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Patients enrolled into the trial must have left ventricular ejection fraction of <40% by echocardiogram within 6 months of enrollment
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
see inclusion/exclusion
Inclusion Criteria:
Patients enrolled into the trial must meet all of the following criteria:
Exclusion Criteria:
Patients meeting one or more of the following criteria are not eligible for randomization into the trial:
Responsible Party: | Cleveland CLinic ( Anne Kanderian, MD ) |
Study ID Numbers: | NORDIC |
Study First Received: | February 16, 2006 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00293137 History of Changes |
Health Authority: | United States: Institutional Review Board |
Chronic systolic heart failure Heart Failure |
Vasodilator Agents Heart Failure Neurotransmitter Agents Heart Diseases Antioxidants Dilated Cardiomyopathy Cardiomyopathy, Dilated Anti-Asthmatic Agents |
Cardiovascular Agents Cardiomyopathies Heart Failure, Systolic Nitric Oxide Peripheral Nervous System Agents Cardiomegaly Bronchodilator Agents |
Respiratory System Agents Vasodilator Agents Neurotransmitter Agents Heart Failure Antioxidants Heart Diseases Molecular Mechanisms of Pharmacological Action Cardiomyopathy, Dilated Physiological Effects of Drugs Anti-Asthmatic Agents Cardiovascular Agents Protective Agents |
Cardiomyopathies Pharmacologic Actions Heart Failure, Systolic Nitric Oxide Autonomic Agents Therapeutic Uses Free Radical Scavengers Endothelium-Dependent Relaxing Factors Cardiovascular Diseases Peripheral Nervous System Agents Cardiomegaly Bronchodilator Agents |