Cardiopulmonary Exercise Testing in Severe Mitral Regurgitation

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Hypertension; Mitral Valve Regurgitation

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• Germany
  • Regensburg, Germany, 93053
    • University Hospital Regensburg - Department of Internal Medicine II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Symptomatic, severe mitral regurgitation. Aetiology and treatment of mitral regurgitation do not affect enrollment.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Severe mitral regurgitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
exercise-induced systolic pulmonary arterial pressure	exercise-induced systolic pulmonary arterial pressure measured by stress- echocardiography	Change from Baseline Exercise-Induced Systolic Pulmonary Arterial Pressure at 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital Regensburg
• Investigators: Principal Investigator: Alexander Dietl, MD, University Hospital Regensburg

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2014
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: May 10, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): October 11, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Cardiopulmonary exercise testing; Stress echocardiography; ergospirometry
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Heart Valve Diseases; Hypertension; Mitral Valve Insufficiency; Hypertension, Pulmonary
• Other Study ID Numbers: UHRegensburg1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No