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Not yet recruitingNCT07501481ARMORUpdated Mar 30, 2026

Arrhythmic Risk in Myocarditis Outcome Research

An observational study in Myocarditis Acute and Ventricular Arrhythmia, sponsored by AZ Sint-Jan AV. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by AZ Sint-Jan AV · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,500
Ages
18 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Myocarditis Acute
  • Ventricular Arrhythmia

Keywords

  • acute myocarditis
  • ventricular arrhythmia
  • ventricular tachycardia
  • ventricular fibrillation
03

In context

Tachycardia, Ventricular

431 studies on the registry are indexed under Tachycardia, Ventricular; 119 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 200 across 145 observational studies indexed under Tachycardia, Ventricular.

Browse Tachycardia, Ventricular studies →

Lead sponsor

AZ Sint-Jan AV is the lead sponsor of 58 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All adult patients hospitalized for acute myocarditis proven by imaging or histological criteria

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

Exclusion Criteria:

  • Age \< 18 years
  • Concomitant acute coronary syndrome
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Acute myocarditis

    Patients hospitalized for acute myocarditis confirmed according to current guidelines

    Other: Treatment of acute myocarditis

Interventions

  • OtherTreatment of acute myocarditis

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

06

What researchers measure

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 years

Secondary outcomes

  1. Cardiomyopathy

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

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — The data that support the findings of this study will be available from the corresponding author, Miloud M. CHERBI, upon reasonable request.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07501481
Lead sponsor
AZ Sint-Jan AV
Collaborators
University Hospital, Toulouse, Rennes University Hospital, University Hospital, Montpellier, University Hospital, Bordeaux, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, Poitiers University Hospital
Responsible party
Miloud Cherbi (Dr., AZ Sint-Jan AV) — Principal investigator
First posted
Mar 30, 2026
Start date
Mar 1, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Mar 30, 2026

Study contacts

Miloud M CHERBI, MD
Contact
cherbi.m@chu-toulouse.fr
+33761743831
Clément DELMAS, MD, PhD
Contact
delmas.clement@chu-toulouse.fr
+33561322426

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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