Cardiopulmonary Exercise Testing in Severe Mitral Regurgitation

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03154034

Enrollment

Registered

2017-05-15

Start date

2014-08-13

Completion date

2018-08-31

Last updated

2021-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Valve Regurgitation, Pulmonary Hypertension

Keywords

Stress echocardiography, Cardiopulmonary exercise testing, ergospirometry

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
peak oxygen uptake (peakVO2)	Change from Baseline peakVO2 at 1 year	peak oxygen uptake measured by ergospirometry

Countries

Germany

Outcome results