Ventricular Arrhythmia After Myocarditis in Sportsman

Not Applicable

Recruiting

• Conditions: Myocarditis Acute; Ventricular Arrythmia

• Registration Number: NCT03842592
• Lead Sponsor: University Hospital, Angers

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-28
• Study First Submitted QC: 2019-02-12
• Study First Posted: 2019-02-15
• Study Start: 2019-11-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-25
• Primary Completion: 2025-11
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Complex ventricular arrhythmia	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 Outcome Measures

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

Trial Locations

Locations (4)

Angers University Hospital; 🇫🇷 Angers, France

Brest University Hospital; 🇫🇷 Brest, France

Lariboisière University Hospital - AP-HP; 🇫🇷 Paris, France

Rennes University Hospital; 🇫🇷 Rennes, France