UK Early Mitral Surgery Trial
Research type
Research Study
Full title
A Randomised, Multicentre Study Comparing Early Mitral Valve Repair with Active Monitoring of Care in Patients with Severe Mitral Valve Regurgitation. (UKEMST)
IRAS ID
180352
Contact name
Simon Ray
Contact email
Sponsor organisation
University Hospital of South Manchester NHS FT
Clinicaltrials.gov Identifier
2015-005291-14, EudraCT
Duration of Study in the UK
6 years, 11 months, 30 days
Research summary
The mitral valve is a valve on the left side of the heart that controls the flow of blood between the top chamber, the left atrium and the bottom chamber, the left ventricle. If it leaks it can cause the heart to work harder and this can cause the heart to get bigger and become less efficient as a pump. This can cause symptoms of breathlessness. Patients with badly leaking valves and big hearts or breathlessness need to have an operation to stop the leak.
At the moment we are not sure whether it is best to operate to repair the leaking valve in people with normal sized heart and no breathlessness. In this group of patients some doctors think it is best to watch the patient carefully and wait until the first signs that the heart is under stress before operating to fix the leak. Other doctors think it is best to operate early before any signs that the heart is struggling.
In this trial we are trying to answer the question of which approach is best. We will randomly allocate patients with leaking valves but no symptoms into two groups. One group who will have an operation to fix the leaking valve, the other will be closely watched and will have an operation only if they get breathless or develop an enlarged heart.REC name
North West - Haydock Research Ethics Committee
REC reference
16/NW/0267
Date of REC Opinion
30 Jun 2016
REC opinion
Further Information Favourable Opinion