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Study finishedN/A

MRI in Randomised Cohorts of Asymptomatic AS

Sponsor: University of Leicester

NCT ID: NCT05178368

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Surgical/ Transcatheter aortic valve replacement (procedure)
How long the study runs
Study runs about 58 months (dates as stated)
About the drug or intervention
Surgical/ Transcatheter aortic valve replacement — procedure: The choice of intervention will be made by the local clinical team.
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
202
Started
2021-07-28
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for aortic stenosis, severe
  • • Clinical study - 202 participants
  • • Aortic stenosis is narrowing of the aortic valve, and is the commonest type of valve disease requiring surgery

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with aortic stenosis, severe

Where?

  • • Leicester - Glenfield Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

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 2 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.

More detail

Ongoing randomised control trials (RCT) are testing the strategy of early AVR in asymptomatic severe AS ('The Early surgery in severe ASYmptomatic Aortic Stenosis': EASY-AS and 'Early Valve Replacement guided by Biomarkers of Left Ventricular Decompensation in Asymptomatic Patients with Severe Aortic Stenosis': EVOLVED), and if positive, have the potential to shift the timing of intervention to earlier disease. With TAVR recently being shown to be non-inferior to SAVR in low risk, mostly symptomatic patients, this also has the potential to be extended to asymptomatic patients. MRI studies have shown that up to 50% of those with asymptomatic AS already have scarring (LGE), which is only partially reversible even after AVE, and remains a marker of mortality. It is not known if earlier valve replacement will lead to less scar burden within the myocardium. Patient reported outcome measures (PROM) are increasingly recognised as an important outcome measure of surgery, especially in an elderly population, for whom a significant increase in survival may be neither possible, nor sought by the patient. 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. A comprehensive formal review of PROMS instruments in patients receiving medical treatment for heart failure concluded that the Euroqol (EQ5D) and Minnesota Living with Heart Failure Questionnaire (MLHFQ) were the most appropriate to measure quality of life in this group. Euroqol is the most commonly used generic instrument in Europe, and showed improvement at 1 year post-AVR for severe AS. MLHFQ is a cardiovascular disease-specific tool that has been shown to be reliable, valid and responsive to therapeutic intervention in patients undergoing valve surgery. Understanding the effect of intervention on PROMs can aid shared decision-making and help shape future individualised recommendations. This prospective, observational mechanistic study will maximise the opportunity offered by ongoing RCTs, to try and establish the effect of the two treatment strategies (early vs late AVR) on cardiac reverse remodelling (in particular fibrosis burden), PROMs and peri-operative recovery.

Aortic Stenosis, Severe

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

eGFR

What the study is looking for

  • ✓Willing to and able to consent
  • ✓Participant in an RCT randomising patients with not causing symptoms severe AS to early AVR vs standard care
  • ✓Severe aortic stenosis, as defined by original trial's inclusion criteria
  • ✓not causing symptoms at the time of randomisation in the RCT
  • ✓Willingness to have 1-2 heart MRI scan(s)

Who cannot take part

  • ✗Contra-indication to MRI.
  • ✗eGFR \<30.
  • ✗Severe claustrophobia (precluding MRI).
See the full criteria
Inclusion Criteria: 1. Willing to and able to consent 2. Participant in an RCT randomising patients with asymptomatic severe AS to early AVR vs standard care 3. Severe aortic stenosis, as defined by original trial's inclusion criteria 4. Asymptomatic at the time of randomisation in the RCT 5. Willingness to have 1-2 cardiac MRI scan(s) Exclusion Criteria: 1. Contra-indication to MRI. 2. eGFR \<30. 3. Severe claustrophobia (precluding MRI).

Where Is This Study? (1 UK site)

Glenfield Hospital

Leicester LE3 9QP, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-07