Vericiguat for Ventricular Remodeling in Patients With Heart Failure With Reduced Ejection Fraction After Myocardial Infarction
试验速览
- 阶段
- 不适用
- 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 vericiguat on cardiac remodeling in patients with chronic stable heart failure after myocardial infarction have not been reported. This project aims to clarify the efficacy and safety of vericiguat in patients with chronic heart failure after myocardial infarction. Patients with chronic stable heart failure with reduced ejection fraction after myocardial infarction in the electronic medical records of Qilu Hospital of Shandong University will be selected and divided into two groups: the treatment group received vericiguat in addition to conventional treatment and the control group received conventional treatment only. After 12-month treatment, the effects of vericiguat on cardiac remodeling and function and cardiovascular adverse events will be evaluated. The results are helpful to provide a new treatment strategy for chronic heart failure after myocardial infarction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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;
- •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;
- •Mechanical complications of myocardial infarction;
- •Unable to obtain primary outcome data.
研究组 & 干预措施
Vericiguat and conventional treatment
Vericiguat in addition to conventional treatment
干预措施: Vericiguat Oral Tablet [Verquvo] (Drug)
Vericiguat and conventional treatment
Vericiguat in addition to conventional treatment
干预措施: Prescription Drugs (Drug)
Conventional treatment only
Conventional treatment only
干预措施: Prescription Drugs (Drug)
结局指标
主要结局
LVEDVI=LVEDV/BSA
时间窗: From baseline to the end of 12-month treatment
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