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Clinical Trial NCT07501481 (ARMOR) for Myocarditis Acute, Ventricular Arrhythmia is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Arrhythmic Risk in Myocarditis Outcome Research (ARMOR) 1,500 Observational Long-Term Follow-up

Not yet recruiting
Clinical Trial NCT07501481 (ARMOR) is an observational study for Myocarditis Acute, Ventricular Arrhythmia and is currently not yet recruiting. Enrollment is planned to begin on March 1, 2026 and continue until the study accrues 1,500 participants. Led by AZ Sint-Jan AV, this study is expected to complete by March 31, 2027. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
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,...
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Official Title

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

Conditions
Myocarditis AcuteVentricular Arrhythmia
Other Study IDs
  • ARMOR
  • 2025-137
NCT ID Number
NCT07501481
Start Date (Actual)
2026-03-01
Last Update Posted
2026-03-30
Completion Date (Estimated)
2027-03-31
Enrollment (Estimated)
1,500
Study Type
Observational
Status
Not yet recruiting
Keywords
acute myocarditis
ventricular arrhythmia
ventricular tachycardia
ventricular fibrillation
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Acute myocarditis
Patients hospitalized for acute myocarditis confirmed according to current guidelines
Treatment of acute myocarditis
Standard medical and interventional management of acute myocarditis in accordance with local protocols
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Ventricular arrhythmia
Number of patients with any sustained ventricular arrhythmia episode (≥ 30 seconds), including ventricular tachycardia and ventricular fibrillation
through study completion, an average of 3 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Cardiomyopathy
Number of patients with a new diagnosis of non-ischemic cardiomyopathy
through study completion, an average of 3 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • Age < 18 years
  • Concomitant acute coronary syndrome
AZ Sint-Jan AV logoAZ Sint-Jan AV
Study Responsible Party
Miloud Cherbi, Principal Investigator, Dr., AZ Sint-Jan AV
Study Central Contact
Contact: Miloud M CHERBI, MD, +33761743831, [email protected]
Contact: Clément DELMAS, MD, PhD, +33561322426, [email protected]
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