Arrhythmic Risk in Myocarditis Outcome Research
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAZ Sint-Jan AV
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age < 18 years
Concomitant acute coronary syndrome
Trial population
All adult patients hospitalized for acute myocarditis proven by imaging or histological criteria
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Treatment of acute myocarditis
Other interventionStandard medical and interventional management of acute myocarditis in accordance with local protocols
Treatment groups
1,500 Participants
are divided into 1 treatment groupGroup A: Acute myocarditis1 intervention
Trial outcomes
Primary outcomes
1
Ventricular arrhythmia
Number of patients with any sustained ventricular arrhythmia episode (≥ 30 seconds), including ventricular tachycardia and ventricular fibrillation
Time frame
through study completion, an average of 3 yearsSecondary outcomes
1
Cardiomyopathy
Number of patients with a new diagnosis of non-ischemic cardiomyopathy
Time frame
through study completion, an average of 3 yearsLocations
Sponsors and contacts
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AZ Sint-Jan AV
Lead sponsor
University Hospital, Toulouse
Collaborator
Rennes University Hospital
Collaborator
University Hospital, Montpellier
Collaborator
University Hospital, Bordeaux
Collaborator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Collaborator
Poitiers University Hospital
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: