CardiomyopathyHCM-LGENCT07428031
French Registry: Late Gadolinium Enhancement in Hypertrophic Cardiomyopathy
An observational study of Cardiomyopathy and Hypertrophic Cardiomyopathies, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
This study aims to create a registry of patients with hypertrophic cardiomyopathy, a condition characterized by excessive thickening of the heart muscle. This disease can sometimes lead to serious complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathy, Hypertrophic Cardiomyopathies
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Mar 2036
- 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: The study will include all consecutive patients with a HCM referred for CMR assessment.
Who may be able to join
- Age ≥ 18 years
- Ability to provide informed consent
- HCM diagnosis referred for CMR assessment.
Who cannot join
- Patients unable to provide informed consent,
- Patients with a history of ischemic cardiomyopathy or myocarditis.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Retrospective French Registry of Cardiovascular Magnetic Resonance Late Gadolinium Enhancement in Patients With Hypertrophic Cardiomyopathy
This study aims to create a registry of patients with hypertrophic cardiomyopathy, a condition characterized by excessive thickening of the heart muscle. This disease can sometimes lead to serious complications. Currently, the prognosis of these patients is mainly determined by clinical and echocardiographic parameters. Detection of myocardial fibrosis using cardiac MRI enables better risk stratification for these patients.
- Conditions
- Cardiomyopathy, Hypertrophic Cardiomyopathies
- Keywords
- Cardiac Magnetic Resonance, Cardiomyopathy
- Medical subject headings
- Cardiomyopathies, Cardiomyopathy, Hypertrophic
What is being measured
The primary outcome is the main question the study is designed to answer.
To build a score using the "LGE granularity" concept for all-cause mortality prediction in HCM patients.
All-cause mortality using the electronic French National Registry of Death (Institut National de la Statistique et des Etudes Economiques, INSEE registry).
Measured: From Baseline to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2031 (estimated)
- Study completion1 Mar 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428031
- Sponsor's protocol ID
- APHP251019
- Acronym
- HCM-LGE
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 23 Feb 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 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective French Registry of Cardiovascular Magnetic Resonance Late Gadolinium Enhancement in Patients With Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT07428031
- Acronym / sponsor ID
- HCM-LGE / APHP251019
- Conditions
- Cardiomyopathy, Hypertrophic Cardiomyopathies
- Keywords
- Cardiac Magnetic Resonance, Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2031 (estimated)
- Study completion
- 1 Mar 2036 (estimated)
- First posted
- 23 Feb 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.
This study aims to create a registry of patients with hypertrophic cardiomyopathy, a condition characterized by excessive thickening of the heart muscle. This disease can sometimes lead to serious complications. Currently, the prognosis of these patients is mainly determined by clinical and echocardiographic parameters. Detection of myocardial fibrosis using cardiac MRI enables better risk stratification for these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include all consecutive patients with a HCM referred for CMR assessment.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Ability to provide informed consent
- HCM diagnosis referred for CMR assessment.
Key exclusion criteria (2 listed)
- Patients unable to provide informed consent,
- Patients with a history of ischemic cardiomyopathy or myocarditis.
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
To build a score using the "LGE granularity" concept for all-cause mortality prediction in HCM patients.
Time frame: From Baseline to 5 years
All-cause mortality using the electronic French National Registry of Death (Institut National de la Statistique et des Etudes Economiques, INSEE registry).
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 23 Feb 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathy and Hypertrophic Cardiomyopathies, run by Assistance Publique - Hôpitaux de Paris.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Théo PEZEL, Dr (+33 6 68 72 24 89, theo.pezel@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To build a score using the "LGE granularity" concept for all-cause mortality prediction in HCM patients. (time frame: From Baseline to 5 years). 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 23 Feb 2026.