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Early Mitral ValvE Repair Versus Watchful Waiting for Asymptomatic SEvere Degenerative Mitral Regurgitation (REVERSE-MR)

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ClinicalTrials.gov Identifier: NCT03389542
Recruitment Status : Not yet recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Degenerative mitral regurgitation (MR) due to leaflet prolapse is frequent and can be surgically repaired in the vast majority of patients. Despite the efficacy of mitral valve repair, an ongoing international controversy exists regarding the need to perform early surgery in asymptomatic patients with severe MR and no sign of LV dysfunction in whom the probability of successful and durable repair is very high. In this group of patients, differing views of the risks of uncorrected severe MR exist: considered as benign by those supporting medical "watchful waiting" or associated with significant excess mortality/morbidity by those advocating early surgery. This controversy can only be resolved by a randomized controlled trial which is still lacking.

The main objective is to demonstrate the superiority of early mitral valve repair in patients with asymptomatic severe MR due to leaflet prolapse compared to an initial conservative management in terms of all-cause death and cardiovascular morbidity during five years follow-up.


Condition or disease Intervention/treatment
Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse Procedure: Surgery Other: Clinical interview and echocardiography

Detailed Description:

Experimental group: In patients randomized to early mitral valve repair, surgery will be performed within 3 months after randomization. Clinical interview will be performed at discharge, at 6 months and afterwards yearly until the end of follow-up. Echocardiography will be performed at discharge, at 6 months and at the end of follow-up.

Control group: Patients randomized to initial conservative management will be followed up by clinical interview and echocardiography every 6 months. Patients will be instructed to report any change in functional status in a prompt manner. Surgery will be indicated at the onset of symptoms or if one or more of the following occur during follow-up: LV end-systolic diameter >40mm, LV ejection fraction <60%, recurrent atrial fibrillation, or resting systolic pulmonary artery pressure >50mmHg.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 424 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Comparison of Early Mitral ValvE Repair Versus Watchful Waiting for Asymptomatic SEvere Degenerative Mitral Regurgitation Due to Leaflet Prolapse
Anticipated Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2026
Arms and Interventions

Arm Intervention/treatment
Experimental: Early mitral valve repair
Surgery will be performed within 3 months after randomization. Clinical interview will be performed at discharge, at 6 months and afterwards yearly until the end of follow-up. Echocardiography will be performed at discharge, at 6 months and at the end of follow-up.
Procedure: Surgery
Early mitral valve repair
Active Comparator: Conservative management
Patients will be followed up by clinical interview and echocardiography every 6 months.
Other: Clinical interview and echocardiography
Clinical interview and echocardiography every 6 months.


Outcome Measures

Primary Outcome Measures :
  1. death and occurrence of adverse cardiovascular events [ Time Frame: during 5 years ]
    Time from randomization to the first occurrence of one of the following composite end-point including all-cause death and occurrence of adverse cardiovascular events (heart failure, atrial fibrillation, infective endocarditis, cerebrovascular events).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Asymptomatic patients according history or an exercise test in those able to perform it if there is a doubt about the absence of symptoms
  • Severe (grade IV) degenerative MR due to leaflet prolapse assessed by echocardiography
  • LV ejection fraction by Simpson biplane method ≥60% and LV end-systolic diameter by TM echocardiography ≤40mm
  • Sinus rhythm on the inclusion ECG
  • Pulmonary artery pressure ≤50 mmHg by Doppler echocardiography.
  • High probability of mitral valve repair
  • EuroSCORE II ≤ 3%

Exclusion Criteria:

  • Mitral stenosis or > mild aortic valve disease (stenosis or regurgitation)
  • Congenital heart disease (except patent foramen ovale or atrial septal defect)
  • Patients with cardiac prostheses
  • Previous myocardial infarction
  • Previous cardiac surgery
  • Extra cardiac comorbidity with life expectancy < 5 years
  • Recent history of psychiatric disease (including drug or alcohol abuse)
  • Therapy with an investigational intervention at the time of screening or plan to enrol patient in additional intervention study during participation in this trial
Contacts and Locations

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): NCT03389542


Contacts
Contact: Christophe TRIBOUILLOY, MD, phD 322 087 250 ext 0033 tribouilloy.christophe@chu-amiens.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Principal Investigator: Christophe TRIBOUILLOY, MD, PhD CHU Amiens
More Information

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03389542     History of Changes
Other Study ID Numbers: PI2017_843_0005
2017-A00364-49 ( Registry Identifier: ID-RCB number )
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Prolapse
Mitral Valve Insufficiency
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases