Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myocarditis Panel | Experimental | N=15 patients from 2025, in which management and treatment of arrhythmias and or myocardial dysfunction were driven by the panel |
|
| No Panel | No Intervention | The 15 patients managed and treated for arrhythmias or myocardial dysfunction in 2024 without applying the myocarditis panel |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Follow-up | Recurrences of arrhythmias or myocardial dysfunction at the follow-up | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Bianco, M.D., Ph.D., MSc, FEACVI | Contact | +39 071 596 5527 | francesco.bianco@ospedaliriuniti.marche.it |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Francesco Bianco | Recruiting | Ancona | The Marches | 60126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35779288 | Background | 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. | |
| 34229446 | 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. |
Not provided
Not provided
IPD will be shared upon reasonable requests from other investigators.
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| 31432626 | 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. |
| 32497572 | 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. |
| 37014337 | 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. |
| 33176455 | 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. |
| ID | Term |
|---|---|
| D009205 | Myocarditis |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided