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NCT Number: NCT07501481

Arrhythmic Risk in Myocarditis Outcome Research

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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Key information

Conditions

Myocarditis Acute Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular Ventricular Arrhythmia Ventricular Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment of acute myocarditis

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Cardiomyopathy

    Time frame: through study completion, an average of 3 years

    Number of patients with a new diagnosis of non-ischemic cardiomyopathy

Study contacts

Contact information is provided by the study sponsor or research team.

Clément DELMAS, MD, PhD

CONTACT

[email protected]

+33561322426

Miloud M CHERBI, MD

CONTACT

[email protected]

+33761743831

Sponsors and collaborators

Lead sponsor

AZ Sint-Jan AV

Other

Collaborators

  • Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
  • Poitiers University Hospital
  • Rennes University Hospital
  • University Hospital, Bordeaux
  • University Hospital, Montpellier
  • University Hospital, Toulouse

Registry information

Official study title

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

Acronym: ARMOR

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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