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Hemodynamic Stress Test in Severe Mitral Regurgitation (HEMI)

NCT02961647 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2017-05-17

No results posted yet for this study

Summary

The preferred treatment of organic mitral regurgitation (MR) is mitral valve repair. Optimally this should be timed so late that it commensurate with the risk of surgery and before irreversibly damage of the heart and pulmonary vessels. The aim is to obtain an understanding of the differences between the symptomatic and asymptomatic patient.

The study will test

A: Symptomatic organic MR is characterized by higher filling pressure, and higher stroke work during physical strain compared with asymptomatic MR.

B: The extent of myocardial fibrosis is associated with filling pressure and cardiac index 1 year after mitral valve repair.

C: Filling pressure can be estimated non-invasively by echocardiography. To test this 40 patients with asymptomatic MR and 40 symptomatic will undergo a stress echocardiography with simultaneous echocardiography and invasive measurement of central hemodynamics. In addition a pulmonary function test and cardiac MRI will be performed.

Conditions

  • Mitral Valve Regurgitation

Interventions

PROCEDURE

Mitral valve repair

The intervention is NOT related to the study design. It is a description of patients undergoing surgery vs. not undergoing surgery and this decision is made according to current guidelines (patients are not randomized).

Sponsors & Collaborators

  • Danish Heart Foundation

    collaborator OTHER

  • University of Southern Denmark

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Jacob Møller, Professor · Department of Cardiology, Odense University Hospital

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02961647 on ClinicalTrials.gov