Arrhythmic Risk in Myocarditis Outcome Research (ARMOR)

AZ Sint-Jan AV

Status: Not yet enrolling

Conditions: Myocarditis Acute; Ventricular Arrhythmia

Treatments: Other: Treatment of acute myocarditis

Study type: Observational

Funder types: Other

Identifiers

NCT07501481

2025-137

Details and patient eligibility

About

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

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,500 participants in 1 patient group

Acute myocarditis

Description:

Patients hospitalized for acute myocarditis confirmed according to current guidelines

Treatment:

Other: Treatment of acute myocarditis