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Arrhythmic Risk in Myocarditis Outcome Research

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07501481
Acronym
ARMOR
Enrollment
1500
Registered
2026-03-30
Start date
2026-03-01
Completion date
2027-03-31
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocarditis Acute, Ventricular Arrhythmia

Keywords

acute myocarditis, ventricular arrhythmia, ventricular tachycardia, ventricular fibrillation

Brief 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

Interventions

OTHERTreatment of acute myocarditis

Standard medical and interventional management of acute myocarditis in accordance with local protocols

Sponsors

AZ Sint-Jan AV
Lead SponsorOTHER
University Hospital, Toulouse
CollaboratorOTHER
Rennes University Hospital
CollaboratorOTHER
University Hospital, Montpellier
CollaboratorOTHER
University Hospital, Bordeaux
CollaboratorOTHER
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
CollaboratorOTHER
Poitiers University Hospital
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Ventricular arrhythmiathrough study completion, an average of 3 yearsNumber of patients with any sustained ventricular arrhythmia episode (≥ 30 seconds), including ventricular tachycardia and ventricular fibrillation

Secondary

MeasureTime frameDescription
Cardiomyopathythrough study completion, an average of 3 yearsNumber of patients with a new diagnosis of non-ischemic cardiomyopathy

Contacts

CONTACTMiloud M CHERBI, MD
cherbi.m@chu-toulouse.fr+33761743831
CONTACTClément DELMAS, MD, PhD
delmas.clement@chu-toulouse.fr+33561322426

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026