Skip to content

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07086144
Enrollment
30
Registered
2025-07-25
Start date
2024-01-01
Completion date
2028-12-31
Last updated
2025-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocarditis

Keywords

pediatric myocarditis, Arrhythmias, Myocarditis panel, Etiological therapy, Myocardial dysfunction

Brief 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.

Interventions

DIAGNOSTIC_TESTDetermination 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

Sponsors

Azienda Ospedaliero, Universitaria Ospedali Riuniti
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

15 patients managed and treated in 2024 without applying the myocarditis panel with 15 patients from 2025, in which management and treatment were driven by the panel.

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Arrhythmias durationFrom enrollment to the end of the hospitalisation (maximum of 8 weeks)Total duration of in-hospital arrhythmias assessed by electrocardiography
Myocardial dysfunctionFrom enrollment to the end of the hospitalisation (maximum of 8 weeks)Total duration of myocardial dysfunction assessed by echocardiography

Secondary

MeasureTime frameDescription
Follow-up6 monthsRecurrences of arrhythmias or myocardial dysfunction at the follow-up

Countries

Italy

Contacts

Primary ContactFrancesco Bianco, M.D., Ph.D., MSc, FEACVI
francesco.bianco@ospedaliriuniti.marche.it+39 071 596 5527

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026