Early Mitral ValvE Repair Versus Watchful Waiting for Asymptomatic SEvere Degenerative Mitral Regurgitation

Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse Clinical Trial

— REVERSE-MR  

Official title:

Randomized Comparison of Early Mitral ValvE Repair Versus Watchful Waiting for Asymptomatic SEvere Degenerative Mitral Regurgitation Due to Leaflet Prolapse

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03389542
• Other study ID #: PI2017_843_0005
• Secondary ID: 2017-A00364-49
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2018
• Est. completion date: January 1, 2026

Study information

• Verified date: June 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Christophe TRIBOUILLOY, MD, phD
• Phone: 322 087 250
• Email: tribouilloy.christophe[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 424
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse
• Mitral Valve Insufficiency
• Prolapse

Intervention

Procedure:
• Surgery
Early mitral valve repair

Other:
• Clinical interview and echocardiography
Clinical interview and echocardiography every 6 months.

Locations

Country	Name	City	State
France	CHU Amiens-Picardie	Amiens
France	Centre Cardiologique du Nord	Saint-Denis

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	during 5 years