Skip to main content
Clinical Trials/NCT03154034
NCT03154034
Completed
Not Applicable

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

University Hospital Regensburg1 site in 1 country38 target enrollmentAugust 13, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mitral Valve Regurgitation
Sponsor
University Hospital Regensburg
Enrollment
38
Locations
1
Primary Endpoint
exercise-induced systolic pulmonary arterial pressure
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 13, 2014
End Date
August 31, 2018
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Alexander Dietl

Resident

University Hospital Regensburg

Eligibility Criteria

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

Outcomes

Primary Outcomes

exercise-induced systolic pulmonary arterial pressure

Time Frame: Change from Baseline Exercise-Induced Systolic Pulmonary Arterial Pressure at 1 year

exercise-induced systolic pulmonary arterial pressure measured by stress- echocardiography

Secondary Outcomes

  • peak oxygen uptake (peakVO2)(Change from Baseline peakVO2 at 1 year)

Study Sites (1)

Loading locations...

Similar Trials