Effects of Liraglutide on Left Ventricular Function in Patients With Non-ST-Segment Elevation Myocardial Infarction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- left ventricular ejection fractions
研究概览
简要总结
The investigators planned to evaluate the effects of liraglutide on left ventricular function in patients with non-ST-segment elevation myocardial infarction (NSTEMI).
详细描述
Patients with non-ST-segment elevation myocardial infarction (NSTEMI) are a heterogeneous group with respect to the risk of having a major adverse cardiac event (MACE). Elevation of blood glucose is a common metabolic disorder among patients with acute myocardial infarction (AMI) and is associated with adverse prognosis. Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose. GLP-1 analogues have significant cardiovascular protective effects in patients with AMI. GLP-1 may have antioxidant and anti-inflammatory properties, and protect endothelial function. Studies in conscious, chronically instrumented dogs demonstrated that GLP-1 infusion increases insulin sensitivity and myocardial glucose uptake in postischemic contractile dysfunction and dilated cardiomyopathy. Liraglutide, a GLP-1 analogue, was reported to reduce cardiac rupture and infarct size and improve cardiac output in normal and diabetic mice. Continuous infusion of GLP-1 (1.5 pmol/kg/min) has been shown to improve functional recovery in patients with AMI complicated by decreased left ventricular function GLP-1 could protect against ischemia-reperfusion injury and improve cardiac function in patients with acute ST-segment elevation myocardial infarction. However, the effects of GLP-1 on NSTEMI patients remain unclear. The aim of this study was to evaluate the effects of liraglutide on left ventricular function in patients with NSTEMI.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-ST-segment elevation myocardial infarction (NSTEMI )
排除标准
- •unconscious at presentation
- •had ST-segment elevation acute myocardial infarction
- •NSTEMI requiring emergency percutaneous coronary angiography
- •valvular heart disease
- •cardiogenic shock
- •hypoglycaemia
- •diabetic ketoacidosis
- •had a history of myocardial infarction
- •stent implantation
- •renal insufficiency
- •had previously undergone coronary artery bypass surgery.
研究组 & 干预措施
placebo
placebo (Novo Nordisk, Bagsværd, Denmark); the frequency: Placebo were taken daily; duration: After admission, the patients were treated with 0.6 mg placebo once daily for 2 day, then 1.2 mg placebo for another 2 day, and then 1.8 mg placebo for 3 days.
干预措施: Placebo (Drug)
GLP-1 group
liraglutide (Novo Nordisk, Bagsværd, Denmark); the frequency: Subcutaneous liraglutide were taken daily; duration: 7 days. After admission, the patients were treated with 0.6 mg liraglutide once daily for 2 day, then 1.2 mg liraglutide for another 2 day, and then 1.8 mg liraglutide for 3 days.
干预措施: GLP-1 (Drug)
结局指标
主要结局
left ventricular ejection fractions
时间窗: at 3 months
The primary efficacy endpoint was the effect of liraglutide on left ventricular ejection fractions (LVEF) measured by transthoracic echocardiography at 3 months .
次要结局
- 6-minute walk distance(at 3 months)
- treatment-emergent adverse events(at 3 months)
研究者
Chen Wei Ren, MD
Investigator
Chinese PLA General Hospital