Hypertrophic Cardiomyopathy (HCM)RADIOMICS-OHCMNCT07695272
Radiomics Analysis of CMR Imaging for Arrhythmic Risk Prediction in Hypertrophic Cardiomyopathy, With Longitudinal Risk Reassessment After Mavacamten Therapy in Obstructive Patients
An observational study of Hypertrophic Cardiomyopathy (HCM) and Cardiac Myosin Inhibitors, run by Centro Cardiologico Monzino at 1 site in Italy.
Trial summary
Hypertrophic cardiomyopathy (HCM) is one of the leading causes of sudden cardiac death (SCD), particularly in young and middle-aged individuals. Current arrhythmic risk stratification mainly relies on clinical and imaging-based models, including the ESC HCM Risk-SCD score and guideline-recommended risk markers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy (HCM), Cardiac Myosin Inhibitors
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2026to 1 Jun 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiomics Analysis of CMR Imaging for Arrhythmic Risk Prediction in Hypertrophic Cardiomyopathy, With Longitudinal Risk Reassessment After Mavacamten Therapy in Obstructive Patients (RADIOMICS - OHCM)
Hypertrophic cardiomyopathy (HCM) is one of the leading causes of sudden cardiac death (SCD), particularly in young and middle-aged individuals. Current arrhythmic risk stratification mainly relies on clinical and imaging-based models, including the ESC HCM Risk-SCD score and guideline-recommended risk markers. However, these approaches show only moderate predictive accuracy at the individual level, highlighting the need for novel biomarkers able to improve risk prediction.
Cardiac magnetic resonance (CMR) plays a central role in phenotypic characterization and prognostic assessment of HCM, particularly through the evaluation of late gadolinium enhancement (LGE), a marker of myocardial fibrosis. Recent studies suggest that radiomic analysis of LGE images can identify quantitative features of myocardial scar heterogeneity that provide additional prognostic information beyond conventional fibrosis burden assessment. Radiomics applied to pre-contrast cine CMR sequences may also capture quantitative features related to myocardial shape, texture, and contractile dynamics, potentially associated with myocardial disarray, mechanical alterations, and electromechanical instability.
Integration of CMR radiomics with genetic data may allow a more comprehensive characterization of the arrhythmic substrate in HCM. In obstructive hypertrophic cardiomyopathy (oHCM), left ventricular outflow tract obstruction is a major determinant of symptoms and prognosis. Mavacamten, a selective cardiac myosin inhibitor, has been shown to significantly reduce LVOT gradient and improve symptoms and cardiac remodeling. However, it remains unknown whether CMR radiomics can detect phenotypic changes associated with mavacamten treatment and whether these changes may contribute to dynamic reassessment of arrhythmic risk.
Read the detailed description
This is a prospective, multicenter, non-profit observational study enrolling adult patients diagnosed with hypertrophic cardiomyopathy (HCM) who undergo cardiac magnetic resonance (CMR) imaging as part of routine clinical practice.
The study aims to evaluate the role of CMR radiomics in predicting arrhythmic risk in patients with HCM and to investigate phenotypic evolution in patients with obstructive hypertrophic cardiomyopathy (oHCM) treated with Mavacamten. Specifically, the study will assess whether radiomic features extracted from CMR imaging can improve the identification of patients at risk of malignant ventricular arrhythmic events and whether radiomic analysis can detect phenotypic modifications associated with mavacamten treatment that may contribute to longitudinal reassessment of arrhythmic risk.
Eligible participants will include adult patients with a diagnosis of hypertrophic cardiomyopathy, including both obstructive and non-obstructive forms, who undergo clinically indicated CMR examinations. In addition, the study will include a subgroup of patients with obstructive HCM initiating treatment with mavacamten, for whom both baseline CMR assessment and longitudinal follow-up CMR evaluation will be available.
Approximately 2,000 patients are expected to be enrolled in the study. Clinical data, standard CMR parameters, and radiomic features extracted from imaging sequences will be collected and analyzed in order to develop predictive models for arrhythmic risk stratification and to evaluate potential imaging biomarkers associated with disease progression and treatment-related phenotypic changes.
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Cohort | Adult patients diagnosed with 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 enrolled 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 longitudinal follow-up CMR evaluation will be available |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of malignant ventricular arrhythmic events
- Sustained ventricular tachycardia
- Ventricular fibrillation
- Appropriate implantable cardioverter-defibrillator (ICD) therapy
- Sudden cardiac death Events will be adjudicated based on clinical records, device interrogation data, and death certificates where available.
Measured: 60 months
Secondary outcomes (4)
Longitudinal changes in radiomic features in mavacamten-treated patients
Measured: 60 months
Predictive performance of radiomic models
Measured: 60 months
Incremental prognostic value over ESC and AHA/ACC models
Measured: 60 months
Association between genotype and arrhythmic risk
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Jun 2026
- Primary completion1 Jun 2031 (estimated)
- Study completion1 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic Cardiomyopathy (HCM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria Careggi, Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI), Azienda Ospedaliera di Padova, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
- Responsible party
- Sponsor
- Investigators
- Gianluca Pontone, MD, Principal investigator, Centro Cardiologico Monzino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695272
- Sponsor's protocol ID
- L2-618
- Acronym
- RADIOMICS-OHCM
- Status last verified
- Jun 2026
- First submitted
- 6 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiomics Analysis of CMR Imaging for Arrhythmic Risk Prediction in Hypertrophic Cardiomyopathy, With Longitudinal Risk Reassessment After Mavacamten Therapy in Obstructive Patients (RADIOMICS - OHCM)
- ClinicalTrials.gov ID
- NCT07695272
- Acronym / sponsor ID
- RADIOMICS-OHCM / L2-618
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria Careggi, Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI), Azienda Ospedaliera di Padova, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jun 2031 (estimated)
- Study completion
- 1 Jun 2031 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypertrophic cardiomyopathy (HCM) is one of the leading causes of sudden cardiac death (SCD), particularly in young and middle-aged individuals. Current arrhythmic risk stratification mainly relies on clinical and imaging-based models, including the ESC HCM Risk-SCD score and guideline-recommended risk markers. However, these approaches show only moderate predictive accuracy at the individual level, highlighting the need for novel biomarkers able to improve risk prediction.
Cardiac magnetic resonance (CMR) plays a central role in phenotypic characterization and prognostic assessment of HCM, particularly through the evaluation of late gadolinium enhancement (LGE), a marker of myocardial fibrosis. Recent studies suggest that radiomic analysis of LGE images can identify quantitative features of myocardial scar heterogeneity that provide additional prognostic information beyond conventional fibrosis burden assessment. Radiomics applied to pre-contrast cine CMR sequences may also capture quantitative features related to myocardial shape, texture, and contractile dynamics, potentially associated with myocardial disarray, mechanical alterations, and electromechanical instability.
Integration of CMR radiomics with genetic data may allow a more comprehensive characterization of the arrhythmic substrate in HCM. In obstructive hypertrophic cardiomyopathy (oHCM), left ventricular outflow tract obstruction is a major determinant of symptoms and prognosis. Mavacamten, a selective cardiac myosin inhibitor, has been shown to significantly reduce LVOT gradient and improve symptoms and cardiac remodeling. However, it remains unknown whether CMR radiomics can detect phenotypic changes associated with mavacamten treatment and whether these changes may contribute to dynamic reassessment of arrhythmic risk.
Detailed description
This is a prospective, multicenter, non-profit observational study enrolling adult patients diagnosed with hypertrophic cardiomyopathy (HCM) who undergo cardiac magnetic resonance (CMR) imaging as part of routine clinical practice.
The study aims to evaluate the role of CMR radiomics in predicting arrhythmic risk in patients with HCM and to investigate phenotypic evolution in patients with obstructive hypertrophic cardiomyopathy (oHCM) treated with Mavacamten. Specifically, the study will assess whether radiomic features extracted from CMR imaging can improve the identification of patients at risk of malignant ventricular arrhythmic events and whether radiomic analysis can detect phenotypic modifications associated with mavacamten treatment that may contribute to longitudinal reassessment of arrhythmic risk.
Eligible participants will include adult patients with a diagnosis of hypertrophic cardiomyopathy, including both obstructive and non-obstructive forms, who undergo clinically indicated CMR examinations. In addition, the study will include a subgroup of patients with obstructive HCM initiating treatment with mavacamten, for whom both baseline CMR assessment and longitudinal follow-up CMR evaluation will be available.
Approximately 2,000 patients are expected to be enrolled in the study. Clinical data, standard CMR parameters, and radiomic features extracted from imaging sequences will be collected and analyzed in order to develop predictive models for arrhythmic risk stratification and to evaluate potential imaging biomarkers associated with disease progression and treatment-related phenotypic changes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort | – | –Adult patients diagnosed with 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 enrolled 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 longitudinal follow-up CMR evaluation will be available |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 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
- Initiation of mavacamten therapy according to clinical indication
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite of malignant ventricular arrhythmic events
Time frame: 60 months
* Sustained ventricular tachycardia * Ventricular fibrillation * Appropriate implantable cardioverter-defibrillator (ICD) therapy * Sudden cardiac death Events will be adjudicated based on clinical records, device interrogation data, and death certificates where available.
4 secondary outcomes
Longitudinal changes in radiomic features in mavacamten-treated patients
Time frame: 60 months
Predictive performance of radiomic models
Time frame: 60 months
Incremental prognostic value over ESC and AHA/ACC models
Time frame: 60 months
Association between genotype and arrhythmic risk
Time frame: 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianluca Pontone, MD principal investigator
Centro Cardiologico Monzino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Cardiomyopathy (HCM) and Cardiac Myosin Inhibitors, run by Centro Cardiologico Monzino at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of malignant ventricular arrhythmic events (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.