Effects of Liraglutide on Left Ventricular Function in Chronic Heart Failure Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- left ventricular ejection fraction measured by 3D echocardiography
研究概览
简要总结
The investigators planned to evaluate the effects of liraglutide on left ventricular function in chronic heart failure patients with type 2 diabetes.
详细描述
Heart failure (HF) is a major cause of morbidity and mortality world wide. Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose, and has direct effects on the cardiovascular system. In our previous study, the GLP-1 analogue liraglutide could improve left ventricular function in patients with acute myocardial infarction. However, the effects of GLP-1 on chronic heart failure patients with type 2 diabetes remain unclear. The aim of this study was to evaluate the effects of liraglutide on left ventricular function in chronic heart failure patients with type 2 diabetes.
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 (Investigator, Outcomes Assessor)
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
- •Chronic heart failure patients with type 2 diabetes (NYHA-class I, II or III) were eligible for the study
排除标准
- •CHF (NYHA class IV)
- •Type 1 diabetes
- •Hospitalisation due to incompensated heart disease within 30 days prior to randomisation
- •Myocardial infarction within the past 3 months before screening
- •Coronary revascularisation within the past 3 months before screening
- •Atrial fibrillation with ventricular frequency >100/min in rest
- •ECG suggestive of malignant ventricular arrhythmia
- •Prolonged QT-interval (>500 ms)
- •Valvular heart disease
- •Current myocardial or pericardial infection
- •Obstructive hypertrophic cardiomyopathy
- •Cancer unless in complete remission for ≥5 years
- •Acute pancreatitis
- •Compromised kidney function (eGFR <30 mL/min), dialysis or kidney transplantation
- •History of thyroidea adenoma or carcinoma
研究组 & 干预措施
Control group
drug: placebo (Novo Nordisk, Bagsværd, Denmark); the frequency: Placebo were taken daily; duration: 3 months. After admission, the patients were treated with 0.6 mg placebo once daily for 1 week, then 1.2 mg placebo for another 1 week, and then 1.8 mg placebo to the end.
干预措施: Placebo (Drug)
GLP-1 group
drug: liraglutide (Novo Nordisk, Bagsværd, Denmark); the frequency: Subcutaneous liraglutide were taken daily; duration: 3 months. After admission, the patients were treated with 0.6 mg liraglutide once daily for 1 week, then 1.2 mg liraglutide for another 1 week, and then 1.8 mg liraglutide to the end.
干预措施: GLP-1 (Drug)
结局指标
主要结局
left ventricular ejection fraction measured by 3D echocardiography
时间窗: 3 months
The primary efficacy endpoint was the effect of liraglutide on left ventricular ejection fractions (LVEF) measured by 3D echocardiography at 3 months.
次要结局
- a change in 6-minute walk distance(3 months)
- plasma NT-proBNP levels(3 months)
- differences in the incidences of treatment-emergent adverse events(3 months)
研究者
Shi Yang
director
Chinese PLA General Hospital