Cardiopulmonary Exercise Testing in Severe Mitral Regurgitation

Sponsor

University Hospital Regensburg (Other)

Overall Status

Completed

CT.gov ID

NCT03154034

Collaborator

(none)

Enrollment

Location

48.6

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mitral Valve Regurgitation Pulmonary Hypertension

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

38 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 13, 2014

Actual Primary Completion Date :

Aug 31, 2018

Actual Study Completion Date :

Aug 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Severe mitral regurgitation

Outcome Measures

Primary Outcome Measures

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

peak oxygen uptake (peakVO2) [Change from Baseline peakVO2 at 1 year]
peak oxygen uptake measured by ergospirometry

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Regensburg - Department of Internal Medicine II	Regensburg		Germany	93053

Sponsors and Collaborators

University Hospital Regensburg

Investigators

Principal Investigator: Alexander Dietl, MD, University Hospital Regensburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Alexander Dietl, Resident, University Hospital Regensburg

ClinicalTrials.gov Identifier:

NCT03154034

Other Study ID Numbers:

UHRegensburg1

First Posted:

May 15, 2017

Last Update Posted:

Oct 11, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr. Alexander Dietl, Resident, University Hospital Regensburg

Stress echocardiography

Cardiopulmonary exercise testing

ergospirometry

Additional relevant MeSH terms:

Hypertension, Pulmonary

Mitral Valve Insufficiency

Study Results

No Results Posted as of Oct 11, 2021