Ventricular Arrhythmia After Myocarditis in Sportsman (ARYMYS)

March 31, 2026 updated by: University Hospital, Angers

Quantification of Ventricular Arrhythmia After Myocarditis in Sportsman

The study aims to assess the prevalence of ventricular rhythmic disorder after an acute myocarditis in sportsmen.

50 patients with acute myocarditis, confirmed by MRI, will be assessed by ECG Holter and Treadmill stress test during a 1-year follow-up.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • Angers University Hospital
      • Brest, France
        • Brest University Hospital
      • Paris, France
        • Lariboisière University Hospital - AP-HP
      • Rennes, France
        • Rennes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • acute myocarditis, diagnosed on the association of (a) recent viral infection (upper airway, gastro-intestinal) , (b) troponin increase, and (c) chest pain AND myocarditis confirmed by cardiac magnetic resonance 2 out of 3 Lake Louise criteria, either T2 hypersignal, early enhancement or late gadolinium enhancement.
  • regular physical activity, recreational or competitive: >=4 hours weekly
  • written informed consent

Exclusion Criteria:

  • coronary artery disease
  • acute inflammatory cardiomyopathy (sarcoidosis, fulminant myocarditis, Tako Tsubo, eosinophilic myocarditis, Lyme disease)
  • history of myocarditis
  • contra-indication to cardiac MRI
  • patient unable to perform a treadmill stress test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: To establish the rhythmic load of sports patients at a distance from a first episode of myocarditis.
Stress testing and 24-hour Holter ECG are the tools currently recommended for assessing rhythmic load and, consequently rhythmic risk. These investigations will be perform at 1 years after myocardite.
Diagnostic test: Treadmill Stress test
Ventricular arrhythmia will be assessed by ECG Holter and during treadmill stress test, both being performed 3 months and 1 year after acute myocarditis
Other Names:
  • ECG Holter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complex ventricular arrhythmia
Time Frame: any timepoint: 3 month and/or 1 year
any ventricular tachycardia (triplet or more), ventricular fibrillation (observed on ECG Holter or during stress test)
any timepoint: 3 month and/or 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital ventricular arrhythmia
Time Frame: up to 2 weeks after admission
any ventricular tachycardia (triplet or more), ventricular fibrillation, recorded on ECG monitoring
up to 2 weeks after admission
Left Ventricular remodeling
Time Frame: between baseline and 3 months
Change in LV volumes during time
between baseline and 3 months
Left ventricular fibrosis
Time Frame: between baseline and 3 months
Change in interstitial fibrosis by T1 mapping cardiac magnetic resonnance
between baseline and 3 months
Major adverse cardio vascular event
Time Frame: up to 2 years after inclusion
CV death, sudden cardiac death, cardiac graft or haemodynamic support, hospitalisation for heart failure, new event of myocarditis
up to 2 years after inclusion
return to physical activity
Time Frame: up to 2 years after inclusion
defined as at least 75% of exercising time (in hours per week)
up to 2 years after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Loïc BIERE, MD PhD, Department of Cardiology, University Hospital of Angers (France)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2019

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

January 28, 2019

First Submitted That Met QC Criteria

February 12, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-A03328-47

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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