Cardiopulmonary Exercise Testing in Severe Mitral Regurgitation - a Single Center, Observational Echocardiographic Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- exercise-induced systolic pulmonary arterial pressure
研究概览
简要总结
The purpose of this study is the evaluation of cardiac and pulmonary response to cardiopulmonary exercise in severe mitral regurgitation and its variation under treatment (surgical mitral valve repair, percutaneous mitral valve repair, optimal medical treatment). The study is conducted as a prospective, observational, single-center study. Patients suffering from symptomatic severe mitral regurgitation will be eligible, if they are referred to the University Hospital of Regensburg, Germany, for further diagnostic procedures and heart team discussion. Cardiopulmonary exercise testing is performed comprising standardized stress echocardiography as well as ergospirometry. Additional detailed assessment will be conducted including standardized questionary, clinical examination, transesophageal echocardiography and measurement of biomarkers.
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
- •symptomatic, severe mitral regurgitation
- •referral for diagnostic work-up and heart team discussion
- •declaration of informed consent
排除标准
- •contra-indication for cardiopulmonary stress examination (unstable angina pectoris, left main disease, abnormal electrolyte concentrations, acute decompensation)
- •pregnancy
- •exercise test on treadmill not possible (amputation of lower extremity, severe arthritis of lower extremities)
- •no acceptable acoustic window at rest
结局指标
主要结局
exercise-induced systolic pulmonary arterial pressure
时间窗: Change from Baseline Exercise-Induced Systolic Pulmonary Arterial Pressure at 1 year
exercise-induced systolic pulmonary arterial pressure measured by stress- echocardiography
次要结局
- peak oxygen uptake (peakVO2)(Change from Baseline peakVO2 at 1 year)
研究者
Dr. Alexander Dietl
Resident
University Hospital Regensburg
