An interventional study of Determination of viral genome, bacterial serology, and markers of inflammation in pediatrics diagnosed with myocarditis in Myocarditis, sponsored by Azienda Ospedaliero, Universitaria Ospedali Riuniti. Recruiting at 1 site in Italy. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2025-07-25.
Sponsored by Azienda Ospedaliero, Universitaria Ospedali Riuniti · Not applicable, Interventional, and Treatment
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.
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.
174 studies on the registry are indexed under Myocarditis; 75 are open to participants now.
This study's planned enrollment of 30 is below the median of 80 across 53 interventional studies indexed under Myocarditis.
Browse Myocarditis studies →Azienda Ospedaliero, Universitaria Ospedali Riuniti is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
N=15 patients from 2025, in which management and treatment of arrhythmias and or myocardial dysfunction were driven by the panel
Diagnostic Test: Determination of viral genome, bacterial serology, and markers of inflammation in pediatrics diagnosed with myocarditis
The 15 patients managed and treated for arrhythmias or myocardial dysfunction in 2024 without applying the myocarditis panel
N=15 patients from 2025, in which management and treatment of arrhythmias and or myocardial dysfunction were driven by the panel
Arrhythmias duration
Total duration of in-hospital arrhythmias assessed by electrocardiography
Time frame: From enrollment to the end of the hospitalisation (maximum of 8 weeks)
Myocardial dysfunction
Total duration of myocardial dysfunction assessed by echocardiography
Time frame: From enrollment to the end of the hospitalisation (maximum of 8 weeks)
Follow-up
Recurrences of arrhythmias or myocardial dysfunction at the follow-up
Time frame: 6 months
Plan to share: No — IPD will be shared upon reasonable requests from other investigators.
Started Jan 2024 (actual). Primary completion is estimated for Sep 2025, 20 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Azienda Ospedaliero, Universitaria Ospedali Riuniti