The Dutch Asymptomatic Mitral Regurgitation Trial (Dutch AMR)

UMC Utrecht

Status: Terminated

Conditions: Mitral Valve Insufficiency; Diseases of Mitral Valve; Heart; Disease, Mitral(Valve)

Treatments: Procedure: Early mitral valve repair; Other: Watchful waiting

Study type: Interventional

Funder types: Other

Identifiers

NCT01708265

NL39851.041.12.

Details and patient eligibility

About

The purpose of this study is to compare early mitral valve repair versus a watchful waiting strategy in asymptomatic patients with severe organic mitral valve regurgitation and preserved left ventricular function.

Full description

Severe asymptomatic organic mitral valve (MV) regurgitation with preserved left ventricular (LV) function is a challenging clinical entity as data on the recommended treatment strategy for these patients are scarce and conflicting, which is reflected in current guidelines. European guidelines advocate a more conservative strategy i.e. watchful waiting, with yearly echocardiography, whilst American guidelines are more in favour of early surgery to reconstruct the MV, i.e. MV repair (in contrast to MV replacement) in order to prevent future LV dysfunction and complaints.

A number of non-randomised trials show a favourable outcome of early surgery and the early surgery strategy has shown to be associated with improved long-term survival, decreased cardiac mortality and decreased morbidity compared with the conservative management [citations 1-3]. On the other hand, non-randomised trials describe also that a conservative strategy (i.e. watchful waiting) can be safely accomplished. If facilitated surgery is performed in this population it has proven to be eventually associated with good perioperative and postoperative outcome in 50% of the patients at 10 years when careful follow-up is being carried out [citation 4]. Non-randomised trials inherently have a number of drawbacks. A randomised trial comparing both strategies and objectivising the best treatment strategy has never been performed.

The Dutch AMR (Asymptomatic Mitral Regurgitation) trial is a multicenter, prospective, randomised trial comparing early MV repair versus watchful waiting in asymptomatic patients with severe organic MV regurgitation and preserved LV function [citation 5, 6].

Enrollment: 12 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Asymptomatic
• Severe organic mitral valve regurgitation.
• Preserved left ventricular function (left ventricular ejection fraction >60% and left ventricular end-systolic dimension ≤45 mm)
• The likelihood of MV repair should be more than 90% determined by the local heart team with a cardiologist and cardiothoracic surgeon

Exclusion criteria

• Pulmonary hypertension (>50 mmHg at rest)
• Atrial fibrillation
• Physical inability as determined by the heart team to undergo surgery
• Other life-threatening morbidity
• Higher expected surgical risks in advance, according to the dedicated heart team
• Moderate to severe kidney disease (eGFR less than 30 mL/min)
• Flail leaflet together with a left ventricular end systolic diameter (LVESD) >40 mm

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

12 participants in 2 patient groups

Early mitral valve repair

Active Comparator group

Description:

Early mitral valve repair

Treatment:

Procedure: Early mitral valve repair

Watchful waiting

Active Comparator group

Description:

Watchful waiting

Treatment:

Other: Watchful waiting