Status:
TERMINATED
NORDIC: Nitric Oxide-Derived Oxidants and Regional Endothelial and Diastolic Dysfunction in Dilated Cardiomyopathy
Lead Sponsor:
The Cleveland Clinic
Conditions:
Chronic Systolic Heart Failure (Dilated Cardiomyopathy)
Eligibility:
All Genders
18+ years
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, rosig...
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, physici...
Eligibility Criteria
Inclusion
- Patients enrolled into the trial must meet all of the following criteria:
- Chronic, stable, euvolemic, heart failure optimally treated for at least 3 months with stable doses of ACE inhibitors or angiotensin-receptor blockers and beta-blockers
- Mild-to-moderate signs and/or symptoms of heart failure (NYHA functional Class I-II)
- Left ventricular ejection fraction of \<40% by echocardiogram within 6 months of randomization or enrollment
Exclusion
- Patients meeting one or more of the following criteria are not eligible for randomization into the trial:
- Known or confirmed newly-diagnosed diabetes mellitus (2004 ADA criteria)
- Major cardiovascular event (myocardial infarction, unstable angina, stroke, transient ischemic attack, pulmonary embolism), or major surgery \<1 month of enrollment
- Hospitalization or emergency room visits for heart failure exacerbation, or use of inotropic agents \< 1 month
- NYHA class III or IV
- Current treatment with thiazolidinediones
- Allergy to rosiglitazone, or liver insufficiency (ALT \> 2.5x upper limits of normal)
- Heart failure due to congenital heart disease, primary valvular disease, hypertrophic cardiomyopathy, or heart failure caused by known cardiotoxic agents (e.g. adriamycin)
- End-stage renal failure on renal replacement therapy (dialysis)
- Life expectancy, or expected cardiac transplantation within 12 months of enrollment
- Women who are pregnant, or who are planning on becoming pregnant or are lactating. Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to the time of randomization and must use contraceptive agents
- Unable or unwilling to consent to all components of the protocol. Patients unwilling to undergo 6-month follow-up should not be enrolled.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00293137
Start Date
February 1 2006
End Date
August 1 2007
Last Update
September 19 2008
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195