EXEnatide in Patients Undergoing Coronary Artery Bypass Grafting for Improved glUcose conTrol and hemodynamIc ValuEs
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Cardiac function - echocardiographic parameters
研究概览
简要总结
GLP-1 has not only beneficial effects on glucose metabolism but also direct positive effects on cardiac function and metabolism in both experimental models and in patients with type 2 diabetes mellitus. Clinical data on the effects of GLP-1 agonists on cardiac function and glucose control in patients undergoing cardiac surgery are not known. Based on the results of experimental studies there is a potential for exenatide to positively influence both cardiac function and glucose metabolism in cardiac surgery patients with and without type 2 diabetes mellitus. The primary endpoint of this study is to examine whether pre- and peri-operative administration of exenatide affects perioperative hemodynamics, echocardiographic parameters, necessity of antiarrhythmic and inotropic treatment and glucose control in patients with coronary atherosclerosis and decreased left ventricular function undergoing elective coronary artery bypass grafting operation (CABG). In addition, safety and tolerability of peri-operative administration of exenatide in these patients will be examined as a secondary study objective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective coronary artery bypass grafting operation (CABG)
- •decreased left ventricular (LV) systolic function (EF LV ≤ 50%)
- •Age 18 to 85
- •Signed informed consent
- •Females with childbearing potential have to use appropriate contraceptive measures during the whole study period and 6 months after terminating exenatide infusion (hormonal contraception or double-barrier contraception for both partners)
排除标准
- •allergy to exenatide
- •allergy to insulin
- •mental incapacity or language barrier
- •use of incretin-based therapies <3 months before inclusion in the study
- •diabetic ketoacidosis
- •established autonomic neuropathy
- •history of acute pancreatitis or severe disease of digestive tract
- •renal failure (preoperative creatinine ≥ 180 umol/l)
- •liver failure (coagulation times more than 1.5 times higher without use of anticoagulants)
- •cardiac surgical procedure on valve, thoracic aorta or MAZE procedure
- •pregnancy and lactation
研究组 & 干预措施
Exenatide
Patients with decreased left ventricular function undergoing elective coronary artery by-pass grafting receiving perioperatively i.v. exenatide on top of standard treatment
干预措施: Exenatide (Drug)
结局指标
主要结局
Cardiac function - echocardiographic parameters
时间窗: 90 days after administration of exenatide
* cardiac chamber dimensions * left ventricular systolic function * left ventricular diastolic function * right ventricular systolic function
次要结局
- Number of participants with adverse effects(90 days after administration of exenatide)
研究者
Martin Haluzik
Prof. Martin Haluzik, MD DSc
Charles University, Czech Republic