MRI in Randomised Cohorts of Asymptomatic AS
ConditionAortic Stenosis, Severe
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Leicester
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Contra-indication to MRI.
eGFR <30.
Severe claustrophobia (precluding MRI).
Trial population
Asymptomatic severe aortic stenosis
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Surgical/ Transcatheter aortic valve replacement
Procedure/SurgeryThe choice of intervention will be made by the local clinical team. The timing of intervention will be determined by randomisation as part of the main EASY/EVOLVED trials
Treatment groups
230 Participants
are divided into 2 treatment groupsGroup A: Early aortic valve replacement1 intervention
Group B: Standard care0 interventions
Trial outcomes
Primary outcomes
1
Total amount of fibrosis (measured by LGE on MRI) in those randomised to early AVR vs standard care.
Measured by percentage of late gadolinium enhancement on MRI, between those randomised to early AVR vs standard care.
Time frame
3 yearsSecondary outcomes
1
Differences in patient reported outcome measures (health related quality of life) between the two groups
Measured using the questionnaire EuroQol- 5 (EQ-5D-5L) EuroQol- 5 Dimension is a standardised measure of health-related quality of life and consists of 2 pages. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Time frame
3 years2
Differences in patient reported outcome measures (patient perceptions of living with heart failure) between the two groups
Measured using the Minnesota Living with Heart Failure questionnaire (MLHF) Minnesota Living with Heart Failure questionnaire aids to systematically and comprehensively assess the patient's perceptions of the effects of heart failure and its treatment on his or her daily life. It is a 21-item paper self- administered questionnaire designed as a measure of heart failure, as indicated by its adverse effects on patients' lives. The MLHFQ quantifies a single overall score as a measure of the impact of heart failure on the patient's life.
Time frame
3 years3
Differences in patient reported outcome measures (in assessing functioning and disability in major life domains) between the two groups
Measured using the World Health Organisation Disability Assessment Schedule-2 (WHODAS-2) questionnaire World Health Organisation Disability Assessment Schedule-2 (WHODAS-2) is a standardised cross-cultural measurement of health status assessing functioning and disability in major life domains, that has been shown to be a valid and reliable instrument for assessment of disability. It is a 36-item measure that assesses disability in adults age 18 years and older.
Time frame
3 years4
Difference in peri-operative recovery between the two groups.
Days at home within 30 days of surgery
Time frame
30 days from date of surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Leicester
Lead sponsor
University of Edinburgh
Collaborator
Source ClinicalTrials.gov