Cardiopulmonary Exercise Testing in Severe Mitral Regurgitation

Completed

• Conditions: Pulmonary Hypertension; Mitral Valve Regurgitation

• Registration Number: NCT03154034
• Lead Sponsor: University Hospital Regensburg

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-13
• Study First Submitted: 2017-05-10
• Study First Submitted QC: 2017-05-12
• Study First Posted: 2017-05-15
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-08
• Last Update Posted: 2021-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• symptomatic, severe mitral regurgitation
• referral for diagnostic work-up and heart team discussion
• declaration of informed consent

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
exercise-induced systolic pulmonary arterial pressure	Change from Baseline Exercise-Induced Systolic Pulmonary Arterial Pressure at 1 year	exercise-induced systolic pulmonary arterial pressure measured by stress- echocardiography

Secondary Outcome Measures

Name	Time	Method
peak oxygen uptake (peakVO2)	Change from Baseline peakVO2 at 1 year	peak oxygen uptake measured by ergospirometry

Trial Locations

Locations (1)

University Hospital Regensburg - Department of Internal Medicine II; 🇩🇪 Regensburg, Germany