Myocarditis AcuteMYOCARDITI-LGENCT07394543
French Registry of CMR Late Gadolinium Enhancement in Myocarditis
An observational study of Myocarditis Acute, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Acute myocarditis is a major cause of death in young adults and carries substantial morbidity, including a significant risk of progression to dilated cardiomyopathy. Current diagnostic and therapeutic strategies remain poorly defined, making risk stratification crucial to enable personalized treatments and reduce… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocarditis Acute
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2026to 10 Feb 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 AM referred for CMR assessment.
Who may be able to join
- Age ≥ 18 years
- Ability to provide informed non-opposition
- AM diagnosis confirmed using CMR, fulfilling the modified Lake Louise diagnostic criteria
Who cannot join
- 1. Patients unable to provide informed non-opposition.
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 Myocarditis
Acute myocarditis is a major cause of death in young adults and carries substantial morbidity, including a significant risk of progression to dilated cardiomyopathy. Current diagnostic and therapeutic strategies remain poorly defined, making risk stratification crucial to enable personalized treatments and reduce mortality and major cardiovascular events.
- Conditions
- Myocarditis Acute
- Keywords
- Late Gadolinium Enhancement, Myocarditis
- Medical subject headings
- Myocarditis
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
All-cause mortality defined using the French national registry of death (INSEE).
Measured: From enrollment to the end of follow up at 10 years
Secondary outcomes (4)
All-cause death
Measured: From enrollment to the end of follow up at 10 years
Heart transplantation
Measured: From enrollment to the end of follow up at 10 years
Ventricular arrhythmia
Measured: From enrollment to the end of follow up at 10 years
Hospitalisation for acute heart failure
Measured: From enrollment to the end of follow up at 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start10 Feb 2026 (estimated)
- Primary completion10 Feb 2036 (estimated)
- Study completion10 Feb 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocarditis AcuteStudies 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
- NCT07394543
- Sponsor's protocol ID
- APHP251399
- Acronym
- MYOCARDITI-LGE
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2026
- Last updated
- 6 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 6 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 Myocarditis
- ClinicalTrials.gov ID
- NCT07394543
- Acronym / sponsor ID
- MYOCARDITI-LGE / APHP251399
- Conditions
- Myocarditis Acute
- Keywords
- Late Gadolinium Enhancement, Myocarditis
- 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
- 10 Feb 2026 (estimated)
- Primary completion
- 10 Feb 2036 (estimated)
- Study completion
- 10 Feb 2036 (estimated)
- First posted
- 6 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.
Acute myocarditis is a major cause of death in young adults and carries substantial morbidity, including a significant risk of progression to dilated cardiomyopathy. Current diagnostic and therapeutic strategies remain poorly defined, making risk stratification crucial to enable personalized treatments and reduce mortality and major cardiovascular events.
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 AM referred for CMR assessment.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Ability to provide informed non-opposition
- AM diagnosis confirmed using CMR, fulfilling the modified Lake Louise diagnostic criteria
Key exclusion criteria (1 listed)
- 1. Patients unable to provide informed non-opposition.
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
All-cause mortality
Time frame: From enrollment to the end of follow up at 10 years
All-cause mortality defined using the French national registry of death (INSEE).
4 secondary outcomes
All-cause death
Time frame: From enrollment to the end of follow up at 10 years
Heart transplantation
Time frame: From enrollment to the end of follow up at 10 years
Ventricular arrhythmia
Time frame: From enrollment to the end of follow up at 10 years
Hospitalisation for acute heart failure
Time frame: From enrollment to the end of follow up at 10 years
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 6 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 Myocarditis Acute, 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 1 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 6 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?
All-cause mortality (time frame: From enrollment to the end of follow up at 10 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 6 Feb 2026.