Defining the Role of Insulin Resistance in 'Idiopathic' Dilated Cardiomyopathy
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00466713
Recruitment Status :
(concern over safety of rosiglitazone in heart failure)
This study will investigate the effects of rosiglitazone, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. The primary purpose of the study is to determine whether treatment with an insulin-sensitizing medication will improve the heart's ability to metabolize glucose (sugar).
Condition or disease
Drug: Rosiglitazone therapy
Nondiabetic patients with nonischemic cardiomyopathy who are insulin-resistance or insulin-sensitive based on a fasting homeostasis model assessment (HOMA) value are eligible for the trial. At baseline, a 6-minute walk test is performed, followed by assessment of coronary flow reserve with ammonia-PET imaging before/after adenosine infusion. Subjects are then given an oral glucose load (75g), followed by PET imaging with F-18-fluoro-2-deoxyglucose (FDG). Subjects then begin taking rosiglitazone 4 mg qd x 12 weeks, after which the 6-minute walk test & PET imaging is repeated.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Diagnosis of nonischemic dilated cardiomyopathy, current NYHA class I-II congestive heart failure
History of Stage C-D heart failure with EF ≤ 40% during the course of the disease
Treatment with a stable comprehensive heart failure regimen for at least 3 months (including beta-blockers and ACE-inhibitors or angiotensin receptor blockers unless intolerant)
Age > 18 yrs
Cardiomyopathy due to one of the following:
Ischemic heart disease
Primary valvular lesion
Cardiac resynchronization within the last 3 months
Transaminase values > 2.5 x upper limit of normal or history of liver disease
Diagnosis of diabetes mellitus by:
Diabetes previously diagnosed per patient history
2 or more fasting glucose values > 125 mg/dl
Current NYHA class III or IV heart failure
Serum creatinine > 1.6 mg/dl
History of heart transplantation
Pregnancy or active breast feeding
Hospitalization for decompensated heart failure within 30 days prior to enrollment.