Cardiopulmonary Exercise Testing in Severe Mitral Regurgitation

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03154034
• Other study ID #: UHRegensburg1
• Status: Completed
• Start date: August 13, 2014
• Est. completion date: August 31, 2018

Study information

• Verified date: October 2021
• Source: University Hospital Regensburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension, Pulmonary
• Mitral Valve Insufficiency
• Mitral Valve Regurgitation
• Pulmonary Hypertension

Locations

Country	Name	City	State
Germany	University Hospital Regensburg - Department of Internal Medicine II	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

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

External Links

•   Study center