Hemodynamic Stress Test in Severe Mitral Regurgitation (HEMI) (HEMI)
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ClinicalTrials.gov Identifier: NCT02961647 |
Recruitment Status : Unknown
Verified May 2017 by Rine Bakkestrøm, Odense University Hospital.
Recruitment status was: Recruiting
First Posted : November 11, 2016
Last Update Posted : May 17, 2017
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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.
Condition or disease | Intervention/treatment |
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Mitral Valve Regurgitation | Procedure: Mitral valve repair |
Background
Degenerative mitral valve disease is the most common cause of organic mitral regurgitation in the Western World. The preferred treatment of organic mitral regurgitation 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. According to the current guidelines mitral valve surgery is indicated in symptomatic patients with severe MR or in presence of known risk factors. The optimal timing of surgery is still controversial in the asymptomatic patients without risk factors.
The overall aim of the present study is to obtain a better understanding of the central hemodynamics at rest and during physical exercise in both symptomatic and asymptomatic patients with organic mitral regurgitation, the relation to neurohormonal activation and myocardial fibrosis, and to identify noninvasive echocardiographic measures suitable for estimation of this.
A epidemiologic sub-study aims to asses whether MR is associated with inherence, as familial clustering of mitral regurgitation earlier has been suggested based only mainly on small observational studies, and case reports.
Methods
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 patients with symptomatic MR will undergo a stress echocardiography with simultaneous echocardiography and invasive measurement of central hemodynamics. In symptomatic patients that undergo surgery, the examination will be repeated 1 year after the surgical mitral valve repair.
In addition pulmonary function test, maximal oxygen consumption test and cardiac MRI will be performed.
The Danish Twin Registry and The Danish National Patient Registry will be used to identify twins with MR. The hypothesis is that the concordance rate is higher in monozygotic twins compared to dizygotic twins.
Study Type : | Observational |
Estimated Enrollment : | 80 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | Invasive Hemodynamic Stress Test in Symptomatic and Asymptomatic Mitral Regurgitation |
Study Start Date : | October 2014 |
Estimated Primary Completion Date : | September 2017 |
Estimated Study Completion Date : | September 2017 |
Group/Cohort | Intervention/treatment |
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Asymptomatic patients
Patients with asymptomatic severe mitral valve regurgitation not undergoing surgical repair of the valve.
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Symptomatic patients
Patients with symptomatic severe mitral valve regurgitation undergoing surgical repair of the valve.
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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). |
- Pulmonary artery wedge pressure [ Time Frame: One year after mitral valve replacement ]
- Extent of myocardial fibrosis [ Time Frame: One year after mitral valve replacement ]
- Maximal oxygen consumption [ Time Frame: One year after mitral valve replacement ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years to 95 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Organic mitral valve regurgitation with effective regurgitation orifice (ERO)>0.3 cm2
- Age > 18 years
- Left ventricular ejection fraction (LVEF) > 60% assessed by echocardiography
- Signed informed consent
Exclusion Criteria:
- Poor echocardiographic window
- Inability to perform bicycle exercise testing
- Ischemic or functional (secondary) mitral valve regurgitation
- Chronic atrial fibrillation/flutter
- Hemodynamic significant aortic valve disease assessed by echocardiography.
- Treatment with oral anticoagulants

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02961647
Contact: Jacob Møller, Professor | jacob.moeller1@rsyd.dk |
Denmark | |
Department of Cardiology, Odense University Hospital | Recruiting |
Odense, Odense C, Denmark, 5000 | |
Contact: Rine Bakkestrøm, MD 0045 31164004 rine.bakkestroem@rsyd.dk |
Principal Investigator: | Jacob Møller, Professor | Department of Cardiology, Odense University Hospital |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Rine Bakkestrøm, Principal investigator, Odense University Hospital |
ClinicalTrials.gov Identifier: | NCT02961647 |
Other Study ID Numbers: |
A5130 |
First Posted: | November 11, 2016 Key Record Dates |
Last Update Posted: | May 17, 2017 |
Last Verified: | May 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Hemodynamic stress test Surgical intervention |
Mitral Valve Insufficiency Heart Valve Diseases Heart Diseases Cardiovascular Diseases |