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This study evaluates the drug Rosiglitazone (Avandia) in patients with heart failure and glucose intolerance or Type II diabetes. It included patients over 21 meeting specific heart-function and insulin-resistance criteria, along with age-matched healthy volunteers. It was a Phase 2 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
* INCLUSION CRITERIA: Adult normal volunteers, age matched (55-75 years of age) Adult patients greater than 21 years of age who meet the following criteria: * Heart Failure due to ischemic heart disease or of idiopathic etiology * Depressed LV systolic function, EF less than or equal to 0.45 by Radionuclide Angiography (MUGA) * New York Heart Association Functional Class II or III * Patient stable on current heart failure therapy * Evidence of insulin resistance or type II diabetes on insulin-sensitivity screening * No predicted cardiac revascularization therapy requirements EXCLUSION CRITERIA: Pregnant or lactating History of admission for acute heart failure exacerbation within last one month Acute myocardial infarction within the last three months Cardiac resynchronization pacemaker placement within the last three months Genetic defect known to have induced heart failure Serum creatinine greater than 2.5 mg/dL. Liver transaminase levels greater than 2.5 x upper limit of normal Requirement for insulin therapy to control blood glucose Current use of thiazolidinedione for diabetic control or history of discontinuation of thiazolidinedione therapy following development of side effects Uncontrolled blood glucose levels or the use of insulin therapy to control diabetes Immune compromise including chronic HIV, HBV, and HCV infection Chronic systemic inflammatory disease such as SLE, rheumatoid arthritis, collagen vascular disease Participation in unrelated research involving investigational pharmacological agent 30 days before planned dosing Current alcohol or drug abuse Inability to provide informed consent