NCT07086144

Efficacy of a Myocardial Panel in the Management and Treatment of Pediatric Myocarditis

Efficacy of a Myocardial Panel (Virological, Bacterial and Autoimmune) in the Management and Treatment of Pediatric Myocarditis Complicated With Arrhythmias or Ventricular Dysfunction

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Azienda Ospedaliero, Universitaria Ospedali Riuniti · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to determine the efficacy a of combined management and treatment driven by the systematic determination of viral genome, bacterial serology, and markers of inflammation in pediatric patients (\< 18 years old) diagnosed with myocarditis complicated by arrhythmias (supraventricular and ventricular tachycardias and heart block) or ventricular dysfunction (left ventricular ejection fraction \< 50% or right ventricular fractional area change \< 35%). The main question it aims to answer is: Does this panel help resolve arrhythmias or myocardial dysfunction due to myocarditis during hospitalisation and follow-up? Researchers will compare patients managed and treated in 2024 without applying the myocarditis panel with those enrolled in 2025 who received the panel. Arrhythmias and myocardial dysfunction will be managed in accordance with recent guidelines. Antiviral, antibiotic or immunosuppressive therapies will be implemented in addition to standard therapy when required by the panel.

Detailed description

The Investigators will enrol consecutive pediatric patients (\< 18 years old) presenting with myocarditis complicated by arrhythmias or ventricular dysfunction. The participants will undergo routine daily visits and electrocardiographic and echocardiographic assessment during hospitalisation (within 8 weeks). During follow-up, a routine visit including an echocardiogram, ECG, and blood tests (complete blood count, liver function tests, renal function tests, inflammation indices, and myocardial necrosis tests) will be performed within the first 40 days of discharge; thereafter, every 3 months after discharge for a total of 6 months of follow-up.

Conditions

• Myocarditis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Determination of viral genome, bacterial serology, and markers of inflammation in pediatrics diagnosed with myocarditis	N=15 patients from 2025, in which management and treatment of arrhythmias and or myocardial dysfunction were driven by the panel

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-09-01
• Completion: 2028-12-31
• First posted: 2025-07-25
• Last updated: 2025-07-25

Locations

1 site across 1 country: Italy