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

NCT07086144 | Recruiting

• 1 other identifier: CCPC - SALESI 001/2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocarditis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Arrhythmias duration

  Total duration of in-hospital arrhythmias assessed by electrocardiography

  From enrollment to the end of the hospitalisation (maximum of 8 weeks)

• Myocardial dysfunction

  Total duration of myocardial dysfunction assessed by echocardiography

  From enrollment to the end of the hospitalisation (maximum of 8 weeks)

Secondary Outcomes (1)

• Follow-up

  6 months

Study Arms (2)

Myocarditis Panel

EXPERIMENTAL

N=15 patients from 2025, in which management and treatment of arrhythmias and or myocardial dysfunction were driven by the panel

Diagnostic Test: Determination of viral genome, bacterial serology, and markers of inflammation in pediatrics diagnosed with myocarditis

No Panel

NO INTERVENTION

The 15 patients managed and treated for arrhythmias or myocardial dysfunction in 2024 without applying the myocarditis panel

Interventions

Determination of viral genome, bacterial serology, and markers of inflammation in pediatrics diagnosed with myocarditis DIAGNOSTIC_TEST

N=15 patients from 2025, in which management and treatment of arrhythmias and or myocardial dysfunction were driven by the panel

Myocarditis Panel

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All the consecutive pediatric patients (\< 18 years old) presenting with myocarditis complicated by arrhythmias or myocardial dysfunction

You may not qualify if:

• Refused consent to be included in the study given by parents or legal tutors
• Uncomplicated myocarditis presenting without arrhythmias or myocardial dysfunction

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Ospedali Riuniti: lead

Study Sites (1)

Francesco Bianco

Ancona, The Marches, 60126, Italy

RECRUITING

Related Publications (6)

• Pompa AG, Beerman LB, Feingold B, Arora G. Electrocardiogram changes in pediatric patients with myocarditis. Am J Emerg Med. 2022 Sep;59:49-53. doi: 10.1016/j.ajem.2022.06.027. Epub 2022 Jun 17.

  PMID: 35779288 BACKGROUND

• Law YM, Lal AK, Chen S, Cihakova D, Cooper LT Jr, Deshpande S, Godown J, Grosse-Wortmann L, Robinson JD, Towbin JA; American Heart Association Pediatric Heart Failure and Transplantation Committee of the Council on Lifelong Congenital Heart Disease and Heart Health in the Young and Stroke Council. Diagnosis and Management of Myocarditis in Children: A Scientific Statement From the American Heart Association. Circulation. 2021 Aug 10;144(6):e123-e135. doi: 10.1161/CIR.0000000000001001. Epub 2021 Jul 7.

  PMID: 34229446 BACKGROUND

• Dasgupta S, Iannucci G, Mao C, Clabby M, Oster ME. Myocarditis in the pediatric population: A review. Congenit Heart Dis. 2019 Sep;14(5):868-877. doi: 10.1111/chd.12835. Epub 2019 Aug 21.

  PMID: 31432626 BACKGROUND

• Ammirati E, Veronese G, Bottiroli M, Wang DW, Cipriani M, Garascia A, Pedrotti P, Adler ED, Frigerio M. Update on acute myocarditis. Trends Cardiovasc Med. 2021 Aug;31(6):370-379. doi: 10.1016/j.tcm.2020.05.008. Epub 2020 Jun 1.

  PMID: 32497572 BACKGROUND

• Ammirati E, Moslehi JJ. Diagnosis and Treatment of Acute Myocarditis: A Review. JAMA. 2023 Apr 4;329(13):1098-1113. doi: 10.1001/jama.2023.3371.

  PMID: 37014337 BACKGROUND

• Ammirati E, Frigerio M, Adler ED, Basso C, Birnie DH, Brambatti M, Friedrich MG, Klingel K, Lehtonen J, Moslehi JJ, Pedrotti P, Rimoldi OE, Schultheiss HP, Tschope C, Cooper LT Jr, Camici PG. Management of Acute Myocarditis and Chronic Inflammatory Cardiomyopathy: An Expert Consensus Document. Circ Heart Fail. 2020 Nov;13(11):e007405. doi: 10.1161/CIRCHEARTFAILURE.120.007405. Epub 2020 Nov 12.

  PMID: 33176455 BACKGROUND

MeSH Terms

Conditions

Myocarditis; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

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

CONTACT

+39 071 596 5527; francesco.bianco@ospedaliriuniti.marche.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 25, 2025
• Study Start: January 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)