RIPCOM 1
Research type
Research Study
Full title
The Right Ventricular- Pulmonary Circulation Continuum in Mitral Valve Disease Study: The RIPCOM 1 Study
IRAS ID
199676
Contact name
Prakash Punjabi
Contact email
Sponsor organisation
Joint Research Compliance Office, Imperial College London
Duration of Study in the UK
2 years, 1 months, 17 days
Research summary
The mitral valve is a structure that separates the left atrium which receives blood from the lungs and the left ventricle which pumps blood to the body. It opens to allow blood from the left atrium and closes when the left ventricle is full of blood to prevent back flow into the lungs. A leaky mitral valve (mitral regurgitation) is one of the most common heart valve conditions presenting for heart surgery. A narrow mitral valve (mitral stenosis) is uncommon in the Western world, but causes a significant burden of disease worldwide.
The indications for surgery include symptoms, or asymptomatic status with heart enlargement or impaired heart function, irregular heart beat or high blood pressure in the lungs (pulmonary hypertension). Currently the only indication with significant clinical trial data is symptoms, however this leads to worse long term survival. The other indications are mostly based on expert opinion rather than significant clinical trials. Hence the point between symptoms and asymptomatic status at which patients would derive definite benefit remains unclear and controversial.
In this study, we will be studying patients who will already be referred and accepted for surgery on the mitral valve. They will undergo pre-operative tests which are regarded as the optimum work up and quality of life questionnaires and be followed up with non-invasive tests and repeat questionnaires after surgery. The results of these tests will be fed back their own doctors to help with long term management. We will also take small heart muscle samples during surgery to look at microscopic changes.
We believe the results of this study will provide us with information that will significantly improve the current evidence base with the aim of establishing when patients should be referred for surgery before developing worse long term survival.
REC name
London - Harrow Research Ethics Committee
REC reference
16/LO/2127
Date of REC Opinion
13 Jan 2017
REC opinion
Further Information Favourable Opinion