Arrhythmic Risk in Myocarditis Outcome Research

NCT07501481 — Not yet recruiting, 1500 participants, AZ Sint-Jan AV

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Incidence, Clinical Impact, and Prediction of Ventricular Arrhythmia in Patients With Acute Myocarditis

Registry	NCT07501481, acronym ARMOR
Status	Not yet recruiting
Study type	Observational
Enrollment	1500 (Estimated)
Sponsor	AZ Sint-Jan AV (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
Conditions	Myocarditis Acute, Ventricular Arrhythmia
Interventions	Treatment of acute myocarditis (Other)
Dates	start 2026-03-01 (estimated), primary completion 2026-12-31 (estimated), completion 2027-03-31 (estimated), first posted 2026-03-30, last updated 2026-03-30

-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). 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

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+Arms and interventions

Arm	Type	Interventions	Description
Acute myocarditis		Other: Treatment of acute myocarditis	Patients hospitalized for acute myocarditis confirmed according to current guidelines

Treatment of acute myocarditis (Other): Standard medical and interventional management of acute myocarditis in accordance with local protocols

+Outcome measures

Primary outcomes

Ventricular arrhythmia [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

Secondary outcomes

Cardiomyopathy [through study completion, an average of 3 years]: Number of patients with a new diagnosis of non-ischemic cardiomyopathy

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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

Exclusion Criteria:

* Age < 18 years
* Concomitant acute coronary syndrome