Efficacy and Mechanism of Exenatide on Improving Heart Function in Type 2 Diabetes With Heart Failure Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 234
- 主要终点
- The change in plasma NT-proBNP level after using exenatide for 4 weeks
研究概览
简要总结
The study evaluates the efficacy of heart function improvements in type 2 diabetes and heart failure patients with exenatide, and also investigates the mechanisms of exenatide improving heart function.
详细描述
The study enrolls 234 patients with type 2 diabetes and heart failure. The patients have an New York Heart Association (NYHA) functional class of II to IV, are randomly assigned to 2 groups. One group use exenatide , the other group is control group and each group has 117 patients. At the baseline, the 3rd day, the 28th day patients are required to complete the heart failure examination: plasma N-terminal pro-B-type natriuretic peptide(NT-proBNP), 6-min walking distance, echocardiographic measures, patient quality of life(MLHFQ). At the end of 4-week follow-up, we evaluate the efficacy of heart function improvements after treatment with exenatide and also investigate the mechanisms of exenatide improving heart function .
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed Type 2 diabetes mellitus
- •HbA1c 7%-10% and Fasting plasma glucose(FBG) <10mmol/L
- •Age 18-65 years
- •NT-proBNP level≥ 450 pg/ml
- •Left ventricular ejection fraction (LVEF)<40%
排除标准
- •Uncorrected primary vascular disease
- •congenital heart disease
- •Left ventricular outflow obstruction
- •Myocarditis
- •uncontrolled severe arrhythmia
- •cardiogenic shock
- •unstable angina, or acute myocardial infarction
- •Severe primary hepatic, renal, or hematologic disease
- •Cr>194.5 mmol/l or K+>5.5 mmol/l
- •Systolic blood pressure (SBP) ≥180mm Hg or diastolic blood pressure (DBP) ≥110mm Hg
- •Alanine aminotransferase (ALT) >3 times the upper normal limit
- •Patients were likely to undergo coronary artery bypass graft surgery during the following 4 weeks
- •Patients had undergone or were likely to undergo cardiac resynchronization therapy
- •Pregnant or lactating known
- •Suspected to be allergic to the study drugs
- •Use dipeptidyl peptidase-4 (DPP-4) or glucagon-like peptide-1 (GLP-1) drug in 3 months
- •Hyperthyroidism and Hypothyroidism
- •Received another investigational drug within 30 days prior to randomization
- •Severe mental health condition or other uncontrolled systemic disease.
研究组 & 干预措施
Exenatide
exenatide group receive exenatide (5μg, subcutaneous injection, Bid）
干预措施: Exenatide (Drug)
结局指标
主要结局
The change in plasma NT-proBNP level after using exenatide for 4 weeks
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
YanYan Chen
Director，endocrinology and cardiology centre
Chinese Academy of Medical Sciences, Fuwai Hospital