Evaluating early valve replacement in asymptomatic aortic stenosis patients
Impact of Early Valve Replacement on Myocardial Scar in Asymptomatic Aortic Stenosis: an Observational MRI Study of Randomised Cohorts
This study is testing if doing heart valve surgery early for people with severe aortic stenosis who don’t have symptoms can help prevent heart damage compared to waiting until they show symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 230 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Leicester Academic / other |
| Locations | 1 site (Leicester, Leicestershire) |
| Trial ID | NCT05178368 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of early aortic valve replacement (AVR) in patients with asymptomatic severe aortic stenosis (AS) compared to standard care, which typically waits for symptoms to develop. It aims to assess whether early intervention can reduce myocardial scarring, as detected by cardiac MRI, which is associated with worse outcomes. The study is part of ongoing randomized control trials that explore the timing of surgical intervention and its effects on patient health. Participants will undergo 1-2 cardiac MRI scans to evaluate changes in heart scarring over time.
Who should consider this trial
Good fit: Ideal candidates are asymptomatic patients diagnosed with severe aortic stenosis who are willing to participate in a randomized trial.
Not a fit: Patients with contraindications to MRI, severe claustrophobia, or significantly impaired kidney function (eGFR <30) may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved heart health and survival rates for patients with severe aortic stenosis by enabling earlier treatment.
How similar studies have performed: Other studies have shown promising results with early intervention strategies in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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 this trial is running
Leicester, Leicestershire
- Glenfield Hospital — Leicester, Leicestershire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Anvesha Singh, Dr — University of Leicester
- Study coordinator: Anvesha Singh, Dr
- Email: as707@leicester.ac.uk
- Phone: +44 116 252 3183
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.