Early valve surgery for severe asymptomatic aortic stenosis (EVoLVeD)
Research type
Research Study
Full title
Early Valve Replacement guided by Biomarkers of Left Ventricular Decompensation in Asymptomatic Patients with Severe Aortic Stenosis
IRAS ID
196827
Contact name
Marc Dweck
Contact email
Duration of Study in the UK
3 years, 6 months, 1 days
Research summary
Aortic stenosis is the most common valvular disease in the Western world. It is caused by progressive narrowing of the aortic valve leading to increased strain on the heart muscle which has to work increasingly hard to pump blood through the narrowed valve. Over time the heart muscle thickens to generate more force, but eventually the heart fails leading to death if the valve is not replaced with an operation. No medical treatments exist to stop or reverse the heart valve narrowing. Current clinical guidelines suggest that an operation should be performed only when symptoms develop or the heart muscle is visibly weak on cardiac ultrasound scanning. However, symptoms can be difficult to interpret and in many patients the heart muscle has become irreversibly damaged and the heart fails to recover following surgery.
Using MRI scans of the heart, we have identified heart scarring which seems to develop as the heart muscle thickens. Several studies now show that people who have developed this scarring are more likely to suffer poor outcomes including death. We have also identified clinical risks (ECG changes and changes in troponin, a protein found in your blood) that predict the presence of scarring.
We propose a study where patients with severe aortic stenosis but no indications for valve replacement as per current guidelines are assessed for those clinical risks. If their risk of having scarring is higher they will undergo a cardiac MRI scan. If scarring is present we will then randomise them into routine clinical care, or referral for valve replacement surgery. Patients with no evidence of scarring will be randomised routine care with study follow or not. We hypothesize that early surgery will lead to fewer complications and reduced risk of death compared to standard care.
REC name
South East Scotland REC 02
REC reference
17/SS/0052
Date of REC Opinion
12 May 2017
REC opinion
Further Information Favourable Opinion