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Heart scarring may begin before symptoms — could early valve replacement stop it?

NCT ID NCT05178368

Knowledge-focused Sponsor: University of Leicester Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

Severe aortic stenosis narrows the heart's aortic valve, and current guidelines recommend waiting until symptoms appear before replacing it. But MRI scans show that up to half of patients already have heart scarring by then, which doesn't fully reverse after surgery. This study will use MRI to compare heart scarring in patients randomly assigned to early valve replacement versus watchful waiting, to see if earlier intervention leads to less scarring and better quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
aortic valve replacement (surgical or transcatheter)
What this could lead to
If early valve replacement reduces heart scarring, it could change guidelines to offer surgery before symptoms develop, potentially improving survival and quality of life.
What could go wrong
This is an observational MRI study, not a treatment trial itself. The results depend on the main trials' outcomes, and early surgery carries procedural risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

202 people

The number who actually took part.

Started

Jul 2021

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Asymptomatic severe aortic stenosis

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic stenosis, severe

Contacts and locations

Locations

  • Glenfield Hospital

    Leicester, Leicestershire, LE3 9QP, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.