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Hemodynamic Stress Test in Severe Mitral Regurgitation (HEMI) (HEMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
Danish Heart Foundation
University of Southern Denmark
Information provided by (Responsible Party):
Rine Bakkestrøm, Odense University Hospital

Brief 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.


Condition or disease Intervention/treatment
Mitral Valve Regurgitation Procedure: Mitral valve repair

Detailed Description:

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.

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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
Asymptomatic patients
Patients with asymptomatic severe mitral valve regurgitation not undergoing surgical repair of the valve.
Symptomatic patients
Patients with symptomatic severe mitral valve regurgitation undergoing surgical repair of the valve.
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).




Primary Outcome Measures :
  1. Pulmonary artery wedge pressure [ Time Frame: One year after mitral valve replacement ]

Secondary Outcome Measures :
  1. Extent of myocardial fibrosis [ Time Frame: One year after mitral valve replacement ]
  2. Maximal oxygen consumption [ Time Frame: One year after mitral valve replacement ]

Biospecimen Retention:   Samples Without DNA
Blood and tissue samples


Information from the National Library of Medicine

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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
Study Population
In the research project the investigators will examine 80 patients with severe MR, of which 40 do not experience symptoms.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Jacob Møller, Professor jacob.moeller1@rsyd.dk

Locations
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Denmark
Department of Cardiology, Odense University Hospital Recruiting
Odense, Odense C, Denmark, 5000
Contact: Rine Bakkestrøm, MD    0045 31164004    rine.bakkestroem@rsyd.dk   
Sponsors and Collaborators
Odense University Hospital
Danish Heart Foundation
University of Southern Denmark
Investigators
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Principal Investigator: Jacob Møller, Professor Department of Cardiology, Odense University Hospital
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Keywords provided by Rine Bakkestrøm, Odense University Hospital:
Hemodynamic stress test
Surgical intervention
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases