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Active, Not Recruiting

NCT Number: NCT03842592

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Myocarditis Acute Ventricular Arrythmia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Angers University Hospital, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treadmill Stress test

Diagnostic 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

Primary outcomes

  1. 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)

Secondary outcomes

  1. In-hospital ventricular arrhythmia

    Time frame: up to 2 weeks after admission

    any ventricular tachycardia (triplet or more), ventricular fibrillation, recorded on ECG monitoring

  2. Left Ventricular remodeling

    Time frame: between baseline and 3 months

    Change in LV volumes during time

  3. Left ventricular fibrosis

    Time frame: between baseline and 3 months

    Change in interstitial fibrosis by T1 mapping cardiac magnetic resonnance

  4. 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

  5. return to physical activity

    Time frame: up to 2 years after inclusion

    defined as at least 75% of exercising time (in hours per week)

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

Quantification of Ventricular Arrhythmia After Myocarditis in Sportsman

Acronym: ARYMYS

Important dates

Study start
2019
Primary completion
2027
Study completion
2028
First posted
Feb 15, 2019
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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