Using a myocarditis panel to guide treatment in children
Official title: Efficacy of a Myocardial Panel (Virological, Bacterial and Autoimmune) in the Management and Treatment of Pediatric Myocarditis Complicated With Arrhythmias or Ventricular Dysfunction
Run by Azienda Ospedaliero, Universitaria Ospedali Riuniti · NCT07086144 · Data updated 2026-11-12
This will test whether using a combined viral genome, bacterial serology, and inflammation panel to guide treatment helps children under 18 with myocarditis who have arrhythmias or reduced heart function.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Azienda Ospedaliero, Universitaria Ospedali Riuniti Academic / other |
| Locations | 1 site (Ancona, The Marches) |
| Status | Recruiting |
| Started | January 1, 2024 |
| Main results expected | September 1, 2025 |
| Study ends | December 31, 2028 |
| Registry record updated | July 25, 2025 |
| Trial ID | NCT07086144 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children younger than 18 years diagnosed with myocarditis complicated by supraventricular or ventricular arrhythmias, heart block, or ventricular dysfunction (LVEF <50% or RV FAC <35%).
✕Probably not a fit
Children with uncomplicated myocarditis without arrhythmias or ventricular dysfunction, or those whose parents/legal guardians do not consent, are not expected to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational, before-and-after study compares consecutive pediatric myocarditis patients managed without the panel in 2024 to those managed with the panel in 2025. Patients will have systematic testing for viral genomes, bacterial serology, and inflammation markers, with arrhythmias and ventricular dysfunction managed according to current guidelines. Antiviral, antibiotic, or immunosuppressive therapies may be added based on panel results in addition to standard care. Daily ECG and echocardiographic assessments will be performed during hospitalization and scheduled follow-up visits with blood tests and cardiac imaging will continue for six months.
Why it matters
Potential benefit: If successful, the panel-guided approach could allow faster, more targeted treatments that help resolve arrhythmias or improve heart function in children with complicated myocarditis.
How similar studies have gone: Some adult and limited pediatric reports suggest pathogen-directed therapy can help select myocarditis cases, but robust, systematic pediatric data using a combined panel are sparse and this approach is relatively novel in children.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Francesco Bianco
Ancona, The Marches, Italy Recruiting
Study contacts
- Study coordinator: Francesco Bianco, M.D., Ph.D., MSc, FEACVI
- Email: francesco.bianco@ospedaliriuniti.marche.it
- Phone: +39 071 596 5527
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.