跳至主要内容
临床试验/NCT03154034
NCT03154034已完成不适用

Cardiopulmonary Exercise Testing in Severe Mitral Regurgitation - a Single Center, Observational Echocardiographic Study

University Hospital Regensburg1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2014年8月13日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Alexander Dietl

Resident

University Hospital Regensburg

研究点 (1)

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