Study on the Clinical and Mechanism of Wenyang Huoxue Decoction in Treating Heart Failure After Myocardial Infarction
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
This study is a randomized, double-blind, placebo-controlled, parallel clinical trial in a Chinese population with heart failure after myocardial infarction. The objective is to observe the efficacy and safety of Wenyang huoxue fang in the treatment of heart failure after myocardial infarction.
详细描述
Currently, there is a lack of high-quality evidence-based support for TCM treatment of heart failure after myocardial infarction. In addition, previous studies have found that the method of warming Yang and activating blood circulation is effective in treating coronary heart disease, and the core pathogenesis of heart failure after myocardial infarction is also Yang deficiency and blood stasis. Therefore, this project aims to evaluate the clinical value of warming Yang and activating blood circulation in the treatment of heart failure after myocardial infarction. Through pharmacological research and detection, the efficacy of Wenyang huoxue prescription in heart failure rats after intervention of myocardial infarction was evaluated, mir-233-ISO signaling pathway was detected before and after treatment, and its mechanism of action was further clarified from the perspective of epigenetics and classical pathway of heart failure.
Objective To investigate the efficacy and safety of Wenyang Huoxue fang in the treatment of heart failure after myocardial infarction.
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 grade II-IV;
- •LVEF 40% 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 ;
- •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 Wenyang Huoxue Decoction, one dose per day, administered in two doses, 150-200 mL each time, for 12 weeks.
干预措施: Wenyang Huoxue 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: Wenyang Huoxue placebo (Drug)
结局指标
主要结局
Major cardiovascular events
时间窗: One months to 1 year after drug intervention
The number of major cardiovascular events，These include death, myocardial infarction, and rehospitalization
次要结局
- Main observation indicators(Into the group day 1, week 4, week 8, week 12)
- Secondary observation index(Into the group day 1, week 4, week 8, week 12)
研究者
Jun Li
Chief physician
Guang'anmen Hospital of China Academy of Chinese Medical Sciences