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Heart scan AI could predict sudden cardiac death risk in common heart condition

NCT ID NCT07695272

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This study looks at whether detailed analysis of heart MRI images (called radiomics) can better predict life-threatening heart rhythms in people with hypertrophic cardiomyopathy (HCM), a condition where the heart muscle thickens. Researchers will also see if the drug mavacamten, which helps relieve obstruction in some HCM patients, leads to changes in these imaging features that might lower risk over time. The goal is to improve current risk prediction tools, which are only moderately accurate.

What this could mean

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

Active substance
mavacamten
What this could lead to
If successful, this could lead to more accurate, personalized risk assessments for sudden cardiac death in people with hypertrophic cardiomyopathy, and show whether mavacamten treatment changes that risk over time.
What could go wrong
This is an observational and exploratory study, not a treatment trial. The radiomics approach is still being tested and may not improve prediction enough to change clinical practice. Results may take years to confirm.

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

2,000 people

The number who actually took part.

Started

Jun 2026

Expected to finish

Jun 2031

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.

Who is studied

Adult patients with a diagnosis of hypertrophic cardiomyopathy (HCM), including both obstructive and non-obstructive forms, undergoing clinically indicated cardiac magnetic resonance (CMR) imaging as part of routine clinical practice will be included in the study. The study will also include a subgroup of patients with obstructive hypertrophic cardiomyopathy (oHCM) initiating treatment with mavacamten, for whom both baseline CMR assessment and follow-up CMR evaluation will be available.

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: * Age ≥ 18 years at the time of enrollment * Diagnosis of hypertrophic cardiomyopathy (HCM) according to current ESC guideline criteria, defined as left ventricular wall thickness unexplained solely by loading conditions * Availability of a clinically indicated cardiac magnetic resonance (CMR) examination performed according to standard protocols and of sufficient diagnostic quality for radiomic analysis * Written informed consent for participation in the study and for data processing, when required by applicable regulations and local center procedures For the subgroup of patients with obstructive HCM treated with mavacamten only: * Initiation of mavacamten therapy according to clinical indication * Availability of baseline CMR and follow-up CMR performed at a later time point Exclusion Criteria: * Age \< 18 years * Absence of a diagnosis of hypertrophic cardiomyopathy according to current ESC guideline criteria * Presence of phenocopies of hypertrophic cardiomyopathy or other structural cardiac diseases that may interfere with phenotypic characterization of HCM, including but not limited to cardiac amyloidosis, Fabry disease, infiltrative or storage cardiomyopathies, and other forms of secondary left ventricular hypertrophy not consistent with HCM * Inadequate quality of cardiac magnetic resonance (CMR) images for radiomic analysis, including motion artifacts, low spatial resolution, incomplete acquisitions, or lack of technical adequacy of required sequences * Absence of required CMR sequences for the planned analyses (in particular cine and/or late gadolinium enhancement \[LGE\] sequences) * Inability to achieve reliable myocardial segmentation in relevant sequences due to technical or anatomical reasons * Prior septal reduction therapy (surgical myectomy or alcohol septal ablation), when such intervention substantially alters myocardial morphology and prevents meaningful comparison with native phenotype radiomic analysis

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Centro Cardiologico Monzino; IRCCS

    Milan, Milan, 20133, Italy

More trials for these conditions

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