NCT Number: NCT07086144
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.
Interested in participating?
Request InfoUp to 18 year
All sexes
Interventional
Not applicable
Ancona, The Marches, 60126, Italy
Location status: Recruiting
Alessandra Palpacelli, M.D.
SUB_INVESTIGATOR
Alessia Omenetti, M.D., Ph.D.
SUB_INVESTIGATOR
Bianca Lattanzi, M.D., Ph.D.
SUB_INVESTIGATOR
Emanuela Berton, M.D.
SUB_INVESTIGATOR
Federica Zallocco, M.D.
SUB_INVESTIGATOR
Francesca C. Surace, M.D.
SUB_INVESTIGATOR
Francesco Bianco, M.D., Ph.D., MSc., FEACVI
CONTACT
Valentina Bucciarelli, M.D., Ph.D.
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
N=15 patients from 2025, in which management and treatment of arrhythmias and or myocardial dysfunction were driven by the panel
Time frame: From enrollment to the end of the hospitalisation (maximum of 8 weeks)
Total duration of in-hospital arrhythmias assessed by electrocardiography
Time frame: From enrollment to the end of the hospitalisation (maximum of 8 weeks)
Total duration of myocardial dysfunction assessed by echocardiography
Time frame: 6 months
Recurrences of arrhythmias or myocardial dysfunction at the follow-up
Contact information is provided by the study sponsor or research team.
Azienda Ospedaliero, Universitaria Ospedali Riuniti
Other
Efficacy of a Myocardial Panel (Virological, Bacterial and Autoimmune) in the Management and Treatment of Pediatric Myocarditis Complicated With Arrhythmias or Ventricular Dysfunction
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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