Development and Validation of the Prediction Model for Functional Mitral Regurgitation Regression in Heart Failure Patients Taking Guideline-directed Medical Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- FMR regression rate
研究概览
简要总结
This observational study is to develop and validate the prediction model for functional mitral regurgitation regression in heart failure patients taking GDMT. The patients diagnosed ≥2+ functional mitral regurgitation by ultrasonic cardiogram are enrolled in this study and would be clinically followed by at least one year (clinical visit at 3 months, 6 months, and 12 months), and then by when the endpoints are reached.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age>18 years old
- •Receiving GDMT
排除标准
- •degenerative mitral regurgitation
- •myocardial infarction, percutaneous coronary intervention, coronary bypass grafting surgery, cardiac resynchronization therapy, or stroke within three months prior to this study
- •≥2+ aortic stenosis or regurgitation
- •previous surgical mitral valve repair or replacement
- •restrictive cardiomyopthy, hypertrophic cardiomyopathy, or constrictive pericarditis
- •severe heart failure (NYHA class IV) or left ventricular ejection fraction < 20%
- •symptomatic hypotension affecting GDMT prescription
- •severe hepatic or renal insufficiency
- •life expectancy < 12 months
- •Pregnancy
研究组 & 干预措施
Regression group
Regression group contains the patients whose FMR regresses after taking GDMT for at least 3 months.
干预措施: angiotensin-converting enzyme inhibitors/angiotensin II receptor blocker/angiotensin receptor-neprilysin inhibitor (Drug)
Regression group
Regression group contains the patients whose FMR regresses after taking GDMT for at least 3 months.
干预措施: The development of the prediction model (Other)
No-reaction group
No-reaction group contains the patients whose FMR has no regression by every clinical visit.
干预措施: angiotensin-converting enzyme inhibitors/angiotensin II receptor blocker/angiotensin receptor-neprilysin inhibitor (Drug)
结局指标
主要结局
FMR regression rate
时间窗: 3 months
the rate of FMR regression by at least 1 grade by 3 months
次要结局
- FMR regression rate(6 months)
- composite endpoint(one year)