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Heart MRI could predict when valve patients need surgery

NCT ID NCT02747485

Knowledge-focused Sponsor: Assistance Publique Hopitaux De Marseille 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a special MRI scan can detect early scarring in the heart muscle of people with leaky heart valves. The goal is to find a way to predict when the heart might start to fail, so doctors can decide on surgery sooner. About 316 adults with moderate to severe valve disease will be followed to see how scarring relates to heart function over time.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 316 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2016

Expected to finish

Nov 2026

An estimate. End dates often move.

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.

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: * All consecutive patients referred for organic MR and/or AR at least moderate to severe according to the ESC guidelines criteria⁴ will be eligible. The moderate to severe criteria will defined by echocardiography as followed: * MR: an effective regurgitant orifice area (EOA) \>30mm2 and/or a regurgitant volume (RV) \>45mL * AR: an EOA \>20mm2 and/or a RV \>45mL Exclusion Criteria: * Age \< 18 years * Pregnancy * Impossibility to maintain a decubitus position * Arrhythmia that do not allow an ECG synchronization during MRI * Hemodynamic instability * Indication of urgent surgery * Known coronary artery disease * Severe arterial hypertension * Cardiomyopathy * Claustrophobia * Gadolinium intolerance * Implantable medical devices that do allow to perform MRI * Severe renal insufficiency with clearance \<35 mL/min * Vulnerable patients * Acute infective endocarditis * Aortic dissection * Moderate or severe mitral stenosis (mitral area \<1.5cm2/m2) * Moderate or severe aortic stenosis (aortic area \<0.8cm2/m2, or Vmax\>3m/s, or mean gradient\>30mmHg) * Previous cardiac surgery

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Conditions

The condition(s) this trial relates to.

aortic valve insufficiency heart valve disorder mitral valve insufficiency

As listed by the trial registrant

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

Valve heart diseases

Contacts and locations

Locations

  • Assistance Publique Hopitaux de Marseille

    Marseille, Bouche DU Rhone, 13354, France

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