Mechanisms of Excess Risk in Aortic Stenosis (The MASTER Study)
Research type
Research Study
Full title
Mechanisms of Excess Risk in Aortic STEnosis after Aortic Valve Replacement (MASTER)
IRAS ID
257307
Contact name
Thomas Treibel
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2019/08/45, UCL Data Protection Office; MRC0240, Barts Charity Reference number; WT2592032, UCL Biomedical Research Centre
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Aortic stenosis is caused by narrowing of one of the main heart valves. When the narrowing becomes severe, replacing the valve is the only treatment to prevent death. Even after we replace the valve, half of patients are left with permanent damage of the heart muscle and a quarter die within 3.5 years. We assume that the heart muscle damage causes abnormal electrical and pumping function of the heart, leading to death, but we do not know.
We want to change this by understanding why and how patients with aortic stenosis and heart muscle damage are dying and what we can do to prevent this.
In this study, we will use a heart scan (MRI) to detect the damage. After valve replacement, patients will receive a tiny monitor (paper clip size), which we inject underneath the skin. This monitor continuously checks the heartbeat and sends any abnormalities wirelessly to our hospital. We will monitor patients for 3 years to see if the damage causes abnormal electrical and pumping function. We will also collect blood samples at each study visit and ask patients to complete questionnaires about their quality of life.
In three sub-studies will
1. Test if we can do the heart scan 3 times as fast.
2. Investigate how the heart recovers 1-year after the valve is replaced.
3. Compare the changes on the heart scan with those on a small heart sample taken at the time of surgery.Once we know how and why, we can design studies to target patients with available medications and specialised treatments like pacemakers or defibrillators, to protect them at risk from dying due to the damaged heart.
REC name
London - Riverside Research Ethics Committee
REC reference
19/LO/1849
Date of REC Opinion
28 Jan 2020
REC opinion
Further Information Favourable Opinion