NORDIC: Nitric Oxide-Derived Oxidants and Regional Endothelial and Diastolic Dysfunction in Dilated Cardiomyopathy

Stopped early

Conditions studied: Chronic Systolic Heart Failure (Dilated Cardiomyopathy)

In brief

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.

Key facts

Study ID

NCT00293137

Run by

The Cleveland Clinic

People needed

60

Starts

2006-02-01

Expected to finish

2007-08-01

Last updated by the study team

2008-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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