Arrhythmic Risk in Myocarditis Outcome Research | NCT07501481

Studies
Arrhythmic Risk in Myocarditis Outcome Research

NCT07501481

Sponsor

AZ Sint-Jan AV

Status

Not yet recruiting

Last Update Posted

Mar 30, 2026Actual

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Myocarditis Acute
Ventricular Arrhythmia

Interventions

Treatment of acute myocarditis

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2026Estimated

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Mar 31, 2027Estimated

First Submitted Date

Mar 23, 2026

First Submission Date that Met QC Criteria

Mar 26, 2026

First Posted Date

Mar 30, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2026

Last Update Posted Date

Mar 30, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Miloud Cherbi, Dr., AZ Sint-Jan AVPrincipal Investigator

Lead Sponsor

AZ Sint-Jan AVOTHER

Collaborators

Name	Class
University Hospital, Toulouse	OTHER
Rennes University Hospital	OTHER
University Hospital, Montpellier	OTHER
University Hospital, Bordeaux

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acute myocarditis		Patients hospitalized for acute myocarditis confirmed according to current guidelines	Other: Treatment of acute myocarditis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Treatment of acute myocarditis	Other	Standard medical and interventional management of acute myocarditis in accordance with local protocols	Acute myocarditis

Outcomes Module

Primary Outcomes

Measure	Description	Time 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 Outcomes

Measure	Description	Time Frame
Cardiomyopathy	Number of patients with a new diagnosis of non-ischemic cardiomyopathy	through study completion, an average of 3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility 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:

Age < 18 years
Concomitant acute coronary syndrome

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

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

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

The data that support the findings of this study will be available from the corresponding author, Miloud M. CHERBI, upon reasonable request.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017180	Tachycardia, Ventricular
D014693	Ventricular Fibrillation

Ancestor Terms

ID	Term
D013610	Tachycardia
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided