Defining the Role of Insulin Resistance in 'Idiopathic' Dilated Cardiomyopathy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 试验地点
- 2
- 主要终点
- Myocardial glucose uptake (intrasubject before/after rosiglitazone)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Cardiomyopathy due to one of the following:
- •Ischemic heart disease
- •Primary valvular lesion
- •Hypertrophic cardiomyopathy
- •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.
结局指标
主要结局
Myocardial glucose uptake (intrasubject before/after rosiglitazone)
Myocardial glucose uptake (between insulin-resistant & insulin-sensitive groups)
次要结局
- Coronary flow-reserve
- 6-minute walk time
研究者
Michael Fowler
Professor of Medicine
Stanford University