Edinburgh Clinical Trials

EVoLVeD

Early Valve Replacement guided by Biomarkers of Left Ventricular Decompensation in Asymptomatic Patients with Severe Aortic Stenosis

The aortic valve can be thought of as a one-way door through which blood leaves the heart to enter the body. It has to be able to open well to allow blood out and close properly to stop blood leaking back and overloading the heart.

Aortic stenosis is a condition where the aortic valve becomes progressively narrowed (stenosed; i.e. the door doesn’t open very well) usually over a number of years or decades. This is usually caused by hardening and thickening of the valve so that it becomes less flexible. This puts a strain on the heart muscle as it has to work harder to “open the door” and pump blood through the narrowed valve. For many years the heart adapts and copes with this increased pressure but eventually it is no longer able to cope and patients develop symptoms (chest pain, breathlessness, collapse) and an increased risk of heart failure and dying. The only treatment currently available for severe aortic stenosis is surgery to replace the narrowed valve. The timing is key: replace the valve too early and patients are put through surgery and the risk of a replacement valve without reason; too late and patients may be left with irreversible symptoms and heart failure. At the moment we replace the valve when patients first develop symptoms but these can be tricky to assess in patients with lots of other health conditions or in those that are inactive. As a consequence the timing of aortic valve operations is often suboptimal.

Fibrosis or scarring of the heart is one of the key processes that causes the heart to fail in this condition. Scarring once formed does not appear reversible, so any scar that forms prior to valve replacement will remain with the patient even after surgery. Using cardiac MRI (a completely safe method of scanning the heart involving strong magnetic fields and lying in a tunnel) we are able to detect the earliest stages of this scarring. We believe this will identify patients whose hearts are starting to fail (even before they develop symptoms) and who therefore need prompt replacement of their valves.

In our study we will use cardiac MRI to look for heart scarring in patients with severe aortic stenosis but no symptoms. Patients with confirmed heart scarring will then be randomised to either early valve replacement surgery or to the current treatment strategy. This consists of continued monitoring of the valve over time waiting for patients to develop symptoms.

We believe that performing aortic valve replacement on patients with severe aortic stenosis with no symptoms but who have evidence of early scarring on cardiac MRI will prevent further scarring from forming, reduce subsequent heart failure and lead to improved long-term symptoms following surgery (e.g. breathlessness) and a reduced chance of dying. The aim of this trial is to find out whether this is correct.

 

Chief Investigator: Dr Marc Dweck

Number and location of participating sites (by region/ country): 25 sites in the UK

 

NCT number (clinicaltrials.gov):  NCT03094143

 

Funder: Sir Jules Thorn Charitable Trust

Start and End date

Of grant award: June 2016 – May 2021

Of recruitment:  August 2017 -

 

Current status: Recruiting

 

GDPR Privacy Statement: If you have participated in this study and would like to read how it complies with GDPR, please read this document. 

 

Sponsor: ACCORD  http://www.accord.ed.ac.uk/

Chief Investigator: Dr Marc Dweck, Centre for Cardiovascular Sciences, Chancellor's Building, 49 Little France Crescent, Edinburgh, EH16 4SB, marc.dweck@ed.ac.uk

Trial manager: Chris Tuck, evolved.trial@ed.ac.uk

 

ECTU Involvement: Trial management / Statistics / Database

(UKCRC)

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