Efficacy of a Myocardial Panel in the Management and Treatment of Pediatric Myocarditis
NCT ID: NCT07086144
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
30 participants
INTERVENTIONAL
2024-01-01
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Outcome of Clinical Phenotypes of Pediatric Myocarditis at Assiut University Children Hospital
NCT07175948
Descriptive and Retrospective Analysis of Acute Myocarditis Associated With Pandemic COVID-19 in Children
NCT04420468
Multiparametric Echocardiography and Cardiac Biomarkers in Pediatric Inflammatory Heart Diseases
NCT05911386
Role of Matrix Metalloproteinases (MMPs) and Tissue Inhibitors of Metalloproteinases (TIMPs) in Children With Myocarditis
NCT00693134
Outcomes Following Medical or Surgical Management of Endocarditis
NCT00166023
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Myocarditis Panel
N=15 patients from 2025, in which management and treatment of arrhythmias and or myocardial dysfunction were driven by the panel
Determination 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
No Panel
The 15 patients managed and treated for arrhythmias or myocardial dysfunction in 2024 without applying the myocarditis panel
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Determination 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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Uncomplicated myocarditis presenting without arrhythmias or myocardial dysfunction
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Azienda Ospedaliero, Universitaria Ospedali Riuniti
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Francesco Bianco
Principal investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Francesco Bianco
Ancona, The Marches, Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CCPC - SALESI 001/2025
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.