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

Azienda Ospedaliero, Universitaria Ospedali Riuniti

Status

Enrolling

Conditions

Myocarditis

Treatments

Diagnostic Test: Determination of viral genome, bacterial serology, and markers of inflammation in pediatrics diagnosed with myocarditis

Study type

Interventional

Funder types

Other

Identifiers

NCT07086144

CCPC - SALESI 001/2025

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All the consecutive pediatric patients (< 18 years old) presenting with myocarditis complicated by arrhythmias or myocardial dysfunction

Exclusion criteria

Refused consent to be included in the study given by parents or legal tutors
Uncomplicated myocarditis presenting without arrhythmias or myocardial dysfunction