Impact of Early Valve Replacement on Myocardial Scar in Asymptomatic Aortic Stenosis: an Observational MRI Study of Randomised Cohorts

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

Aortic stenosis is narrowing of the aortic valve, and is the commonest type of valve disease requiring surgery. Current guidelines recommend waiting till patients develop symptoms (chest pain, breathlessness and dizzy spells/fainting) before possible open heart surgery to replace the valve is offered. However, studies using detailed 'MRI' scanning of the heart have shown that up to half of the patients already have 'scarring' in the heart by the time symptoms develop. Furthermore, scarring is not fully reversed even after surgery and is associated with worse outcome. This suggests that some patients are being offered treatment too late. Two randomised trials in the UK (EASY AS and EVOLVED) are currently investigating if valve replacement before symptoms will result in better survival. The aim of this study is to compare the effect of early valve replacement versus waiting for symptoms, on the amount of scarring in the heart. The investigators want to know if early treatment leads to less overall scarring at the end, and leads to better quality of life and recovery after surgery. The investigators will invite participants of the EASY AS and EVOLVED trials to have 1-2 MRI heart scans: at recruitment and 3 years after being randomly allocated to early aortic valve replacement vs 'watchful waiting'. The investigators will also assess the impact of the two treatment approaches on quality of life, disability-free survival (using questionnaires) and recovery after surgery. The results from this project will increase understanding of the results of the main trials, and lead to improved selection of patients with aortic stenosis who are likely to benefit from early surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Willing to and able to consent

• Participant in an RCT randomising patients with asymptomatic severe AS to early AVR vs standard care

• Severe aortic stenosis, as defined by original trial's inclusion criteria

• Asymptomatic at the time of randomisation in the RCT

• Willingness to have 1-2 cardiac MRI scan(s)

Locations
Other Locations
United Kingdom
Glenfield Hospital
RECRUITING
Leicester
Contact Information
Primary
Anvesha Singh, Dr
as707@leicester.ac.uk
+44 116 252 3183
Time Frame
Start Date: 2021-07-28
Estimated Completion Date: 2031-09-01
Participants
Target number of participants: 230
Treatments
Early aortic valve replacement
Asymptomatic severe aortic stenosis patients randomised to early aortic valve replacement
Standard care
Asymptomatic severe aortic stenosis patients randomised to 'watchful waiting' until symptom onset.
Sponsors
Leads: University of Leicester
Collaborators: University of Edinburgh

This content was sourced from clinicaltrials.gov