Degenerative Mitral Regurgitation (MR) Due to Leaflet ProlapseREVERSE-MRNCT03389542
Early Mitral ValvE Repair Versus Watchful Waiting for Asymptomatic SEvere Degenerative Mitral Regurgitation
A study testing Surgery and Clinical interview and echocardiography in people with Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse, run by Centre Hospitalier Universitaire, Amiens at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse
- What is being tested?
- Surgery and Clinical interview and echocardiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 2 sitesFrance
- Study dates
- 10 Apr 2018to 10 Apr 2033
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHU Amiens-Picardie
Amiens, 80054
- Recruiting
Centre Cardiologique du Nord
Saint-Denis, 93200
Thomas GOISSEN, 01 49 33 41 38 ext. 0033, thomas.goissen@gmail.com
About this study
Official title: Randomized Comparison of Early Mitral ValvE Repair Versus Watchful Waiting for Asymptomatic SEvere Degenerative Mitral Regurgitation Due to Leaflet Prolapse
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.
Read the 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.
- Being tested
- Surgery, Clinical interview and echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Early mitral valve repair
Clinical interview and echocardiographyOther
Clinical interview and echocardiography every 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Early mitral valve repair | Experimental | 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. Receives: Procedure: Surgery |
| Conservative management | Active comparator | Patients will be followed up by clinical interview and echocardiography every 6 months. Receives: Other: Clinical interview and echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
death and occurrence of adverse cardiovascular events
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).
Measured: during 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start10 Apr 2018
- Primary completion10 Apr 2033 (estimated)
- Study completion10 Apr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Mitral Regurgitation (MR) Due to Leaflet ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 424 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe TRIBOUILLOY, MD, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389542
- Sponsor's protocol ID
- PI2017_843_0005
- Other IDs
- 2017-A00364-49
- Acronym
- REVERSE-MR
- Status last verified
- May 2026
- First submitted
- 26 Dec 2017
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No