Myocarditis AcuteARMORNCT07501481
Arrhythmic Risk in Myocarditis Outcome Research
An observational study of Myocarditis Acute and Ventricular Arrhythmia, run by AZ Sint-Jan AV.
Trial summary
The goal of this observational, retrospective, multicenter study is to characterize the arrhythmic burden and identify predictive factors for ventricular arrhythmias (VAs) in adult patients hospitalized for acute myocarditis (AM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocarditis Acute, Ventricular Arrhythmia
- What is being tested?
- Treatment of acute myocarditis
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 31 Mar 2027
- 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: All adult patients hospitalized for acute myocarditis proven by imaging or histological criteria
Who may be able to join
- Age ≥ 18 years
- Hospitalization for acute myocarditis
- Confirmation of the diagnosis of AM by at least one of the following: (1) Cardiac magnetic resonance according to the revised 2018 Lake Louise Criteria; (2) Endomyocardial biopsy according to the Dallas criteria with associated immunohistochemical and molecular criteria; (3) Cardiac computed tomography with compatible late iodine enhancement
Who cannot join
- Age < 18 years
- Concomitant acute coronary syndrome
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: Incidence, Clinical Impact, and Prediction of Ventricular Arrhythmia in Patients With Acute Myocarditis
The goal of this observational, retrospective, multicenter study is to characterize the arrhythmic burden and identify predictive factors for ventricular arrhythmias (VAs) in adult patients hospitalized for acute myocarditis (AM). The main questions it aims to answer are:
- What is the incidence of sustained ventricular arrhythmias during the index hospitalization in patients with acute myocarditis?
- What clinical, biological, electrocardiographic, and imaging factors predict the occurrence of sustained ventricular arrhythmias during hospitalization and after discharge?
Read more
Researchers will compare patients who developed sustained VAs during hospitalization to those who did not, in order to identify independent predictors of arrhythmic events and develop a validated risk stratification score.
Participants' medical records from 2020 to 2024 will be reviewed to collect:
- Baseline demographic, clinical, biological, electrocardiographic, and imaging data at admission
- In-hospital management strategies and outcomes, including mortality, cardiogenic shock, and heart replacement therapy
- Long-term follow-up data including VA recurrence, sudden cardiac death, and development of cardiomyopathy, with censoring applied on January 1, 2026
- Conditions
- Myocarditis Acute, Ventricular Arrhythmia
- Being tested
- Treatment of acute myocarditis
- Keywords
- acute myocarditis, ventricular arrhythmia, ventricular tachycardia, ventricular fibrillation
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of acute myocarditisOther
Standard medical and interventional management of acute myocarditis in accordance with local protocols
| Study group | Role | What they receive |
|---|---|---|
| Acute myocarditis | Patients hospitalized for acute myocarditis confirmed according to current guidelines Receives: Other: Treatment of acute myocarditis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular arrhythmia
Number of patients with any sustained ventricular arrhythmia episode (≥ 30 seconds), including ventricular tachycardia and ventricular fibrillation
Measured: through study completion, an average of 3 years
Secondary outcomes (1)
Cardiomyopathy
Number of patients with a new diagnosis of non-ischemic cardiomyopathy
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (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.
- 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Toulouse, Rennes University Hospital, University Hospital, Montpellier, University Hospital, Bordeaux, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, Poitiers University Hospital
- Responsible party
- Principal investigator, Miloud Cherbi, AZ Sint-Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501481
- Sponsor's protocol ID
- 2025-137
- Acronym
- ARMOR
- Status last verified
- Feb 2026
- First submitted
- 23 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data that support the findings of this study will be available from the corresponding author, Miloud M. CHERBI, upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Clinical Impact, and Prediction of Ventricular Arrhythmia in Patients With Acute Myocarditis
- ClinicalTrials.gov ID
- NCT07501481
- Acronym / sponsor ID
- ARMOR / 2025-137
- Conditions
- Myocarditis Acute, Ventricular Arrhythmia
- Keywords
- acute myocarditis, ventricular arrhythmia, ventricular tachycardia, ventricular fibrillation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Collaborators
- University Hospital, Toulouse, Rennes University Hospital, University Hospital, Montpellier, University Hospital, Bordeaux, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, Poitiers University Hospital
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 30 Mar 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.
The goal of this observational, retrospective, multicenter study is to characterize the arrhythmic burden and identify predictive factors for ventricular arrhythmias (VAs) in adult patients hospitalized for acute myocarditis (AM). The main questions it aims to answer are:
- What is the incidence of sustained ventricular arrhythmias during the index hospitalization in patients with acute myocarditis?
- What clinical, biological, electrocardiographic, and imaging factors predict the occurrence of sustained ventricular arrhythmias during hospitalization and after discharge?
Researchers will compare patients who developed sustained VAs during hospitalization to those who did not, in order to identify independent predictors of arrhythmic events and develop a validated risk stratification score.
Participants' medical records from 2020 to 2024 will be reviewed to collect:
- Baseline demographic, clinical, biological, electrocardiographic, and imaging data at admission
- In-hospital management strategies and outcomes, including mortality, cardiogenic shock, and heart replacement therapy
- Long-term follow-up data including VA recurrence, sudden cardiac death, and development of cardiomyopathy, with censoring applied on January 1, 2026
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute myocarditis | – | Other: Treatment of acute myocarditisPatients hospitalized for acute myocarditis confirmed according to current guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients hospitalized for acute myocarditis proven by imaging or histological criteria
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Hospitalization for acute myocarditis
- Confirmation of the diagnosis of AM by at least one of the following: (1) Cardiac magnetic resonance according to the revised 2018 Lake Louise Criteria; (2) Endomyocardial biopsy according to the Dallas criteria with associated immunohistochemical and molecular criteria; (3) Cardiac computed tomography with compatible late iodine enhancement
Key exclusion criteria (2 listed)
- Age < 18 years
- Concomitant acute coronary syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment of acute myocarditisStandard medical and interventional management of acute myocarditis in accordance with local protocols | Other | Acute myocarditis |
Primary outcome
Ventricular arrhythmia
Time frame: through study completion, an average of 3 years
Number of patients with any sustained ventricular arrhythmia episode (≥ 30 seconds), including ventricular tachycardia and ventricular fibrillation
1 secondary outcome
Cardiomyopathy
Time frame: through study completion, an average of 3 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 30 Mar 2026.
- Individual participant dataSharing planned: Undecided. The data that support the findings of this study will be available from the corresponding author, Miloud M. CHERBI, upon reasonable request.
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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 and Ventricular Arrhythmia, run by AZ Sint-Jan AV.
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 30 Mar 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 Miloud M CHERBI, MD (+33761743831, cherbi.m@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventricular arrhythmia (time frame: through study completion, an average of 3 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 30 Mar 2026.