Heart scan AI could predict sudden cardiac death risk in common heart condition
NCT ID NCT07695272
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.
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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 Hide 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
Other studies related to the condition(s) this trial covers.
- 3,000 hearts, one goal: mapping how hypertrophic cardiomyopathy unfolds in china
- Experimental pill aims to ease thick heart muscle symptoms
- Massive HCM database aims to unlock better heart care
- Heart drug swap tested for safer symptom control
- Real-World HCM drug use under the microscope
- Heart drug mavacamten shows promise in Real-World study