Skip to main content
OpenTrials
Completed

NCT Number: NCT03154034

Cardiopulmonary Exercise Testing in Severe Mitral Regurgitation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mitral Valve Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Hypertension Hypertension, Pulmonary Lung Diseases Mitral Valve Insufficiency Pulmonary Hypertension Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Regensburg - Department of Internal Medicine II

Regensburg, 93053, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. peak oxygen uptake (peakVO2)

    Time frame: Change from Baseline peakVO2 at 1 year

    peak oxygen uptake measured by ergospirometry

Sponsors and collaborators

Lead sponsor

University Hospital Regensburg

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
May 15, 2017
Registry last updated
Oct 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.