Efficacy and Safety of Qishenyiqi Dripping Pills in Patients With Ventricular Remodeling and Chronic Heart Failure With Reduced Ejection Fraction After Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 210
- 试验地点
- 3
- 主要终点
- LVEDVI=LVEDV/BSA
研究概览
简要总结
The effects of Qishenyiqi dripping pill on cardiac remodeling in patients with chronic stable heart failure have not been reported. This project aims to clarify the efficacy and safety of Qishenyiqi in patients with chronic heart failure after myocardial infarction. Patients with chronic stable heart failure after myocardial infarction were selected and randomly divided into two groups: the treatment group was treated with Qishenyiqi dripping pills; The control group was given placebo treatment. After 12 months of follow-up, the effects of Qishenyiqi on cardiac remodeling and function and cardiovascular adverse events were evaluated. The results are helpful to provide a new treatment strategy for chronic heart failure.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The history of acute myocardial infarction exceeds 3 months;
- •Symptoms and signs of heart failure have been stable for more than one month;
- •18 years old or more;
- •NYHA cardiac function classified as grade II~IV;
- •LVEF≤40%；
- •NT-proBNP≥450pg/ml；
- •All subjects or their guardians must sign the subject consent before entering the trial.
排除标准
- •Patients with the following diseases: nonischemic cardiomyopathy; valvular heart disease; congenital heart disease; obstruction of left ventricular outflow tract; severe decompensated heart failure; active myocarditis or pericardial disease; end-stage liver and kidney diseases; malignant tumor;
- •Planned to undergo cardiac surgery within 12 months;
- •Mechanical complications of myocardial infarction;
- •Pregnant or nursing, or having the intention to give birth within one year;
- •Patients who participated in clinical research of other drugs within 3 months before being selected;
- •Patients with poor sound transmission windows are examined by transthoracic ultrasound.
研究组 & 干预措施
Qishenyiqi
干预措施: Qishenyiqi dripping pills (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
LVEDVI=LVEDV/BSA
时间窗: From baseline to 12 months after follow-up
Changes of left ventricular end-diastolic volume index (LVEDVI) compared with baseline after 12 months
次要结局
未报告次要终点
研究者
Pan-Pan Hao
Professor
Qilu Hospital of Shandong University