Actively Recruiting

Phase Not Applicable
Age: 0 - 18Years
All Genders
ID07086144

Efficacy of a Myocardial Panel (Virological, Bacterial and Autoimmune) in the Management and Treatment of Pediatric Myocarditis Complicated With Arrhythmias or Ventricular Dysfunction

Led by Azienda Ospedaliero, Universitaria Ospedali Riuniti · Updated on 2025-07-25

30

Participants Needed

1

Research Sites

173 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the effectiveness of a combined diagnostic panel including viral genome, bacterial serology, and inflammation markers in managing pediatric patients under 18 years old diagnosed with myocarditis complicated by arrhythmias or ventricular dysfunction. The main focus is to determine if this panel helps resolve arrhythmias or heart muscle problems during hospital stays and follow-up. The study compares patients treated in 2024 without the panel to those in 2025 who received panel-guided care, following recent treatment guidelines including antiviral, antibiotic, or immunosuppressive therapies when needed. Participants include pediatric patients with myocarditis complicated by arrhythmias or left or right ventricular dysfunction. The study involves two groups: one managed in 2025 using the diagnostic panel to guide treatment, and another from 2024 managed without the panel. Treatment follows standard care protocols, with additional therapies based on panel results. Management occurs during hospitalization lasting up to 8 weeks. During the study, participants undergo daily routine visits with electrocardiographic and echocardiographic assessments while hospitalized. After discharge, follow-up visits include echocardiograms, ECGs, and blood tests at approximately 40 days and then every 3 months up to six months total. Researchers measure duration of arrhythmias and myocardial dysfunction from enrollment to end of hospitalization, with follow-up monitoring over six months to assess ongoing heart function and recovery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pediatric patients under 18 years old
  • Diagnosed with myocarditis complicated by arrhythmias or myocardial dysfunction
Not Eligible

You will not qualify if you...

  • Parents or legal guardians refuse consent for participation
  • Myocarditis without arrhythmias or myocardial dysfunction

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to 8 weeks

Participants receive management and treatment for arrhythmias or myocardial dysfunction during hospitalization, guided by the myocarditis panel for some.

Routine daily visits during hospitalization

Follow-up

Duration - 6 months

Participants attend routine visits including echocardiogram, ECG, and blood tests within the first 40 days after discharge and every 3 months thereafter for 6 months.

1 visit within 40 days after discharge and visits every 3 months thereafter

Trial Site Locations

Total: 1 location

1

Francesco Bianco

Ancona, The Marches, Italy, 60126

Actively Recruiting

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Research Team

F

Francesco Bianco, M.D., Ph.D., MSc, FEACVI

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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