RAS involvement in myocardial remodelling progression in AS
Research type
Research Study
Full title
Is the renin-angiotensin system involved in the progression of myocardial remodeling in Aortic Stenosis?
IRAS ID
306783
Contact name
Marc Dweck
Contact email
Sponsor organisation
University of Edinburgh
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Aortic stenosis is one of the most common valvular diseases in the western world. This causes the muscle to become scarred (fibrosis) due to stress. There is no medical treatment for aortic stenosis. Angiotensin receptor II blockers (ARB) have shown some benefit and may be involved in the mechanism.
Patients will be approached about the study by the medical team. With consent, the research team will discuss the study and provide the patient with an information sheet. If they consent to take part in the study, they will be randomised to either have ARB (medication used to treat high blood pressure) or placebo (no active drug). Following this, participants will have a baseline visit during which we will complete a physical examination, symptom check, blood tests (check kidney/liver function), 24 hour blood pressure monitor and an ultrasound scan of the heart (Echo). Participants will be given the tablets depending on what arm of the study they have been randomised to. This is a blinded study; neither the participant nor the research member will know if they receive the study drug or placebo. In case of an emergency, we will be able to disclose what medication they are prescribed.
Participants will undergo CT coronary angiography (CTCA, scan of heart arteries) and state-of-the-art scanning technology, combined Positron Emission Tomography and magnetic resonance imaging (PET-MR) with a new tracer, 68Ga-FAPI or 18F-FAPI (a colourless liquid injected in order to take the pictures).
At 1 month and 1 year we will repeat the following procedures performed on the baseline visit: symptom check, bloods, Echo, 24hr BP monitor.
At 2 years we will repeat the following: symptom check, bloods, Echo, 24hr BP monitor, CTCA and PET-MR. During the 2 years we will call patients every 3 months for adverse event monitoring and to renew their prescription.
REC name
South East Scotland REC 01
REC reference
23/SS/0041
Date of REC Opinion
26 Apr 2023
REC opinion
Further Information Favourable Opinion