NCT07501481

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

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Mar 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Mar 2026Mar 2027

Study Start

First participant enrolled

March 1, 2026

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

March 30, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

March 23, 2026

Last Update Submit

March 26, 2026

Conditions

Myocarditis AcuteVentricular Arrhythmia

Keywords

acute myocarditisventricular arrhythmiaventricular tachycardiaventricular fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Cardiomyopathy

    through study completion, an average of 3 years

Study Arms (1)

Acute myocarditis

Patients hospitalized for acute myocarditis confirmed according to current guidelines

Other: Treatment of acute myocarditis

Interventions

Treatment of acute myocarditisOTHER

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

Acute myocarditis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Age \< 18 years
  • Concomitant acute coronary syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tachycardia, VentricularVentricular Fibrillation

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Miloud M CHERBI, MD

CONTACT

+33761743831cherbi.m@chu-toulouse.fr

Clément DELMAS, MD, PhD

CONTACT

+33561322426delmas.clement@chu-toulouse.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 23, 2026

First Posted

March 30, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

March 30, 2026

Record last verified: 2026-02