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

May 16, 2017 updated by: Rine Bakkestrøm, Odense University Hospital

Invasive Hemodynamic Stress Test in Symptomatic and Asymptomatic Mitral Regurgitation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Odense C
      • Odense, Odense C, Denmark, 5000
        • Recruiting
        • Department of Cardiology, Odense University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pulmonary artery wedge pressure
Time Frame: One year after mitral valve replacement
One year after mitral valve replacement

Secondary Outcome Measures

Outcome Measure
Time Frame
Extent of myocardial fibrosis
Time Frame: One year after mitral valve replacement
One year after mitral valve replacement
Maximal oxygen consumption
Time Frame: One year after mitral valve replacement
One year after mitral valve replacement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Collaborators

University of Southern Denmark
Danish Heart Foundation

Investigators

  • Principal Investigator: Jacob Møller, Professor, Department of Cardiology, Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

October 6, 2016

First Submitted That Met QC Criteria

November 8, 2016

First Posted (Estimate)

November 11, 2016

Study Record Updates

Last Update Posted (Actual)

May 17, 2017

Last Update Submitted That Met QC Criteria

May 16, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5130

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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