The PREPARE-MVR Study: PRediction of Early PostoperAtive Right vEntricular Failure in Mitral Valve Replacement/Repair Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- right ventricular failure
研究概览
简要总结
The PREPARE-MVR (PRediction of Early PostoperAtive Right vEntricular failure in Mitral Valve Replacement/Repair patients) Study aims to evaluate those preoperative factors which can predict the early postoperative right ventricular failure or determine the functional shift seen in right ventricular function after mitral valve replacement/repair. The PREPARE-MVR study focuses mainly on echocardiographic (both conventional and advanced) parameters and includes right heart catheterization intraoperatively and in the early postoperative period as gold standard method.
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
- •patients admitted for mitral valve replacement/repair
- •severe mitral valve insufficiency
排除标准
- •preoperative right ventricular dysfunction
- •cardiac surgery in medical history
- •infective endocarditis
- •primary cardiomyopathies
- •congenital heart disease
- •decreased left ventricular ejection fraction
- •pulmonary embolism in medical history
- •severe chronic obstructive pulmonary disease
- •primary pulmonary hypertension
- •any malignancy affecting right heart
结局指标
主要结局
right ventricular failure
时间窗: From date of operation until the date of first documented right ventricular failure assessed up to 6 months
Early postoperative right ventricular failure is defined as right ventricular stroke work index \<300 mmHg/mL/m2 measured by right heart catheterization. Late right ventricular failure is defined as \>10% decrease in right ventricular ejection fraction compared to preoperative value measured by 3D echocardiography.
次要结局
未报告次要终点