Cardiopulmonary Exercise Testing in Severe Mitral Regurgitation

NCT ID: NCT03154034

Last Updated: 2021-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-13

Study Completion Date

2018-08-31

Brief Summary

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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

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Conditions

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Mitral Valve Regurgitation Pulmonary Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Severe mitral regurgitation

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Regensburg

OTHER

Sponsor Role lead

Responsible Party

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Dr. Alexander Dietl

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexander Dietl, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Regensburg

Locations

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University Hospital Regensburg - Department of Internal Medicine II

Regensburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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UHRegensburg1

Identifier Type: -

Identifier Source: org_study_id

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