Clinical and Metabonomics Study on the Treatment of Heart Failure After Myocardial Infarction With Modified Wenxin Decoction
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 主要终点
- Major cardiovascular events
研究概览
简要总结
To elucidate the efficacy and safety of weixin decoction in the treatment of heart failure after myocardial infarction.
详细描述
To elucidate the long-term protective effect of flavored Wenxin Decoction on heart failure after myocardial infarction.
To elucidate the effective components in the treatment of heart failure and the mechanism of metabolism regulation.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old；
- •A history of acute myocardial infarction；
- •Cardiac function Ⅱ - Ⅲ level；
- •LVEF 50% or less;
- •Nt-probnp level ≥ 450 pg/ mL；
- •All men and women can sign the informed consent form.
排除标准
- •Coronary artery bypass grafting was performed within 12 weeks；
- •Undergo or possibly undergo cardiac resynchronization therapy;
- •Primary valvular disease, left ventricular outflow tract obstruction, myocarditis, aneurysm, uncontrolled severe arrhythmia, cardiogenic shock, unstable angina pectoris, or acute myocardial infarction;
- •Having a serious primary liver, kidney or blood system disease or having a serious mental illness or a systemic disease that is out of control;
- •Serum creatinine > 194.5 mol/L or serum potassium > 5.5mmol /L;
- •The level of alanine aminotransferase or alkaline phosphatase is 1.5 times of the normal upper limit of >;
- •Abnormal blood pressure control, systolic blood pressure exceeding 180mmHg or diastolic blood pressure exceeding 110mmHg;
- •Pregnancy or lactation; Known or suspected allergy to research drugs; To receive another investigational drug within 30 days of randomization or to be unwilling or unable to provide written consent.
研究组 & 干预措施
Experimental group
On the basis of basic western medicine treatment (secondary prevention of coronary heart disease + anti-heart failure treatment), Patients in this group will be given modified Wenxin Tang granules, one dose per day, administered in two doses, 150-200 mL each time, for 12 weeks.
干预措施: Modified Wenxin Decoction (Drug)
Control group
On the basis of basic western medicine treatment (secondary prevention of coronary heart disease + anti-heart failure treatment), Patients in this group will be given placebo, one dose per day, administered in two doses, 150-200 mL each time, for 12 weeks.
干预措施: Modified Wenxin Decoction (Drug)
结局指标
主要结局
Major cardiovascular events
时间窗: One months after drug intervention
Rates of cardiac death, acute myocardial infarction, stroke, and heart failure readmission
次要结局
- Secondary indicators(Into the group day 1, week 4, week 8, week 12)
研究者
Jun Li
Li Jun
Guang'anmen Hospital of China Academy of Chinese Medical Sciences