Using a myocarditis panel to guide treatment in children
Efficacy of a Myocardial Panel (Virological, Bacterial and Autoimmune) in the Management and Treatment of Pediatric Myocarditis Complicated With Arrhythmias or Ventricular Dysfunction
NA · Azienda Ospedaliero, Universitaria Ospedali Riuniti · NCT07086144
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliero, Universitaria Ospedali Riuniti (other) |
| Locations | 1 site (Ancona, The Marches) |
| Trial ID | NCT07086144 on ClinicalTrials.gov |
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.
Who should consider this trial
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%).
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Ancona, The Marches
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Myocarditis, pediatric myocarditis, Arrhythmias, Myocarditis panel, Etiological therapy, Myocardial dysfunction