Outcome of Clinical Phenotypes of Pediatric Myocarditis at Assiut University Children Hospital
NCT ID: NCT07175948
Last Updated: 2025-09-16
Study Results
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Basic Information
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NOT_YET_RECRUITING
100 participants
OBSERVATIONAL
2026-06-01
2027-08-01
Brief Summary
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Children aged 1-18 years who are diagnosed with myocarditis based on clinical findings, cardiac biomarkers, echocardiography, and electrocardiography (with MRI when available) will be included. Patients with congenital heart disease or cardiomyopathy unrelated to myocarditis will be excluded.
The study will follow eligible patients prospectively over a 12-month period. Detailed clinical assessment, laboratory tests, echocardiographic findings, and management strategies will be recorded. Special attention will be given to the role of corticosteroids and intravenous immunoglobulin (IVIG) in treatment. Outcomes including recovery of cardiac function, need for intensive care, and survival will be assessed.
By analyzing the clinical presentation, treatment, and prognosis of different myocarditis phenotypes, this study aims to improve the understanding of disease patterns in children and provide evidence to guide future management.
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Detailed Description
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In children, acute myocarditis often follows viral infection and may manifest with fever, chest pain, palpitations, or signs of heart failure. Fulminant myocarditis presents abruptly with severe hemodynamic compromise and cardiogenic shock, requiring intensive care and often mechanical circulatory support. Chronic active myocarditis is associated with ongoing inflammation, progressive ventricular dysfunction, and increased risk of dilated cardiomyopathy. Chronic persistent myocarditis may present with milder, prolonged symptoms but can still result in long-term morbidity.
This prospective cohort study will be conducted at Assiut University Children's Hospital over 12 months. Approximately 30 eligible pediatric patients will be enrolled using consecutive sampling. Inclusion criteria include children aged 1-18 years with clinically and diagnostically confirmed myocarditis. Exclusion criteria include congenital heart disease or cardiomyopathy unrelated to myocarditis.
All participants will undergo comprehensive evaluation including:
Clinical assessment: demographic data, presenting symptoms, signs of cardiac dysfunction, and general/systemic examination.
Laboratory tests: cardiac biomarkers (troponin, CK-MB), inflammatory markers (CRP, ESR), renal and liver function, lactate, and ABG.
Echocardiography: left ventricular dimensions, fractional shortening, ejection fraction, wall motion abnormalities, pericardial effusion, and valve regurgitation.
Electrocardiography and chest X-ray.
Management recording: medical therapy including corticosteroids, IVIG, inotropes, and supportive care.
Primary outcomes: classification of myocarditis phenotypes and assessment of treatment effectiveness, with focus on corticosteroids and IVIG.
Secondary outcomes: clinical improvement, recovery of cardiac function, survival, and requirement of intensive care or mechanical circulatory support.
Statistical analysis will be performed using SPSS. Data will be analyzed using descriptive and analytical methods, including Chi-square, t-tests, correlation, and regression analyses, with significance set at p \< 0.05.
This study will contribute to understanding the spectrum of pediatric myocarditis in a tertiary care setting in Upper Egypt and provide insight into prognostic indicators and therapeutic strategies.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Acute Myocarditis
Children (1-18 years) diagnosed with acute myocarditis, typically following viral illness, presenting with fever, chest pain, heart failure symptoms, or arrhythmias. Diagnosis supported by elevated cardiac biomarkers, echocardiographic findings of LV dysfunction, and ECG changes. Management includes standard medical therapy (inotropes, ACE inhibitors, beta-blockers) and in some cases corticosteroids or IVIG depending on severity.
Standard Medical Therapy
All enrolled children will receive standard medical therapy tailored to clinical status. This includes inotropes (e.g., dopamine, dobutamine, milrinone), ACE inhibitors, beta-blockers, and/or diuretics as indicated. Treatment is supportive and adjusted according to severity of cardiac dysfunction and hemodynamic status. The goal is to stabilize heart failure, improve cardiac output, and prevent progression to dilated cardiomyopathy.
Standard Medical Therapy
All enrolled children will receive standard medical therapy tailored to clinical status. This includes inotropes (dopamine, dobutamine, milrinone), ACE inhibitors, beta-blockers, and/or diuretics as indicated. Therapy is supportive and adjusted according to severity of cardiac dysfunction and hemodynamic status to stabilize heart failure, improve cardiac output, and prevent progression to dilated cardiomyopathy.
2️⃣ Intervention 2
Fulminant Myocarditis
Children presenting with sudden, severe myocarditis characterized by rapid onset of cardiogenic shock, severe LV dysfunction, or multi-organ involvement. Diagnosis based on clinical picture, elevated biomarkers, echocardiography, and ECG. Management frequently requires intensive care, high-dose inotropes, and may include IVIG, corticosteroids, and mechanical circulatory support such as ECMO if indicated.
Standard Medical Therapy
All enrolled children will receive standard medical therapy tailored to clinical status. This includes inotropes (e.g., dopamine, dobutamine, milrinone), ACE inhibitors, beta-blockers, and/or diuretics as indicated. Treatment is supportive and adjusted according to severity of cardiac dysfunction and hemodynamic status. The goal is to stabilize heart failure, improve cardiac output, and prevent progression to dilated cardiomyopathy.
Standard Medical Therapy
All enrolled children will receive standard medical therapy tailored to clinical status. This includes inotropes (dopamine, dobutamine, milrinone), ACE inhibitors, beta-blockers, and/or diuretics as indicated. Therapy is supportive and adjusted according to severity of cardiac dysfunction and hemodynamic status to stabilize heart failure, improve cardiac output, and prevent progression to dilated cardiomyopathy.
2️⃣ Intervention 2
Chronic Active Myocarditis
Children with ongoing inflammatory myocarditis lasting weeks to months, presenting with persistent heart failure symptoms, arrhythmias, or progressive LV dysfunction. Diagnosis confirmed by echo and biomarkers, sometimes MRI. Treatment includes standard therapy for heart failure plus immunomodulation with corticosteroids and/or IVIG in selected cases. Close monitoring is required to prevent progression.
Standard Medical Therapy
All enrolled children will receive standard medical therapy tailored to clinical status. This includes inotropes (e.g., dopamine, dobutamine, milrinone), ACE inhibitors, beta-blockers, and/or diuretics as indicated. Treatment is supportive and adjusted according to severity of cardiac dysfunction and hemodynamic status. The goal is to stabilize heart failure, improve cardiac output, and prevent progression to dilated cardiomyopathy.
Standard Medical Therapy
All enrolled children will receive standard medical therapy tailored to clinical status. This includes inotropes (dopamine, dobutamine, milrinone), ACE inhibitors, beta-blockers, and/or diuretics as indicated. Therapy is supportive and adjusted according to severity of cardiac dysfunction and hemodynamic status to stabilize heart failure, improve cardiac output, and prevent progression to dilated cardiomyopathy.
2️⃣ Intervention 2
Chronic Persistent Myocarditis
Children with a long-term, indolent course of myocarditis, often progressing toward dilated cardiomyopathy. Patients present with signs of chronic heart failure, reduced EF, and persistent LV dilation. Management includes conventional heart failure therapy (ACE inhibitors, beta-blockers, diuretics, inotropes as needed). Corticosteroids or IVIG may be used in selected patients based on clinical status. Long-term follow-up is required.
Standard Medical Therapy
All enrolled children will receive standard medical therapy tailored to clinical status. This includes inotropes (e.g., dopamine, dobutamine, milrinone), ACE inhibitors, beta-blockers, and/or diuretics as indicated. Treatment is supportive and adjusted according to severity of cardiac dysfunction and hemodynamic status. The goal is to stabilize heart failure, improve cardiac output, and prevent progression to dilated cardiomyopathy.
Standard Medical Therapy
All enrolled children will receive standard medical therapy tailored to clinical status. This includes inotropes (dopamine, dobutamine, milrinone), ACE inhibitors, beta-blockers, and/or diuretics as indicated. Therapy is supportive and adjusted according to severity of cardiac dysfunction and hemodynamic status to stabilize heart failure, improve cardiac output, and prevent progression to dilated cardiomyopathy.
2️⃣ Intervention 2
Interventions
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Standard Medical Therapy
All enrolled children will receive standard medical therapy tailored to clinical status. This includes inotropes (e.g., dopamine, dobutamine, milrinone), ACE inhibitors, beta-blockers, and/or diuretics as indicated. Treatment is supportive and adjusted according to severity of cardiac dysfunction and hemodynamic status. The goal is to stabilize heart failure, improve cardiac output, and prevent progression to dilated cardiomyopathy.
Standard Medical Therapy
All enrolled children will receive standard medical therapy tailored to clinical status. This includes inotropes (dopamine, dobutamine, milrinone), ACE inhibitors, beta-blockers, and/or diuretics as indicated. Therapy is supportive and adjusted according to severity of cardiac dysfunction and hemodynamic status to stabilize heart failure, improve cardiac output, and prevent progression to dilated cardiomyopathy.
2️⃣ Intervention 2
Eligibility Criteria
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Inclusion Criteria
* Children diagnosed with myocarditis based on clinical presentation, echocardiography, and cardiac biomarkers, ECG and MRI (if available)
Exclusion Criteria
* Known cardiomyopathy unrelated to myocarditis.
1 Year
18 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Elshymaa Abdelmged Abdelmenaem
resident , pediatric department
Central Contacts
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References
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Yao Q, Zhan S. Corticosteroid in anti-inflammatory treatment of pediatric acute myocarditis: a systematic review and meta-analysis. Ital J Pediatr. 2023 Mar 13;49(1):30. doi: 10.1186/s13052-023-01423-w.
Hajjar LA, Teboul JL. Mechanical Circulatory Support Devices for Cardiogenic Shock: State of the Art. Crit Care. 2019 Mar 9;23(1):76. doi: 10.1186/s13054-019-2368-y.
Kociol RD, Cooper LT, Fang JC, Moslehi JJ, Pang PS, Sabe MA, Shah RV, Sims DB, Thiene G, Vardeny O; American Heart Association Heart Failure and Transplantation Committee of the Council on Clinical Cardiology. Recognition and Initial Management of Fulminant Myocarditis: A Scientific Statement From the American Heart Association. Circulation. 2020 Feb 11;141(6):e69-e92. doi: 10.1161/CIR.0000000000000745. Epub 2020 Jan 6.
Jayashree M, Patil M, Benakatti G, Rohit MK, Singhi S, Bansal A, Baranwal A, Nallasamy K, Angurana SK. Clinical Profile and Predictors of Outcome in Children with Acute Fulminant Myocarditis Receiving Intensive Care: A Single Center Experience. J Pediatr Intensive Care. 2021 Jan 25;11(3):215-220. doi: 10.1055/s-0040-1722339. eCollection 2022 Sep.
Garbern JC, Gauvreau K, Blume ED, Singh TP. Is Myocarditis an Independent Risk Factor for Post-Transplant Mortality in Pediatric Heart Transplant Recipients? Circ Heart Fail. 2016 Jan;9(1):e002328. doi: 10.1161/CIRCHEARTFAILURE.115.002328. Epub 2015 Dec 23.
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.
Lasica R, Djukanovic L, Savic L, Krljanac G, Zdravkovic M, Ristic M, Lasica A, Asanin M, Ristic A. Update on Myocarditis: From Etiology and Clinical Picture to Modern Diagnostics and Methods of Treatment. Diagnostics (Basel). 2023 Sep 28;13(19):3073. doi: 10.3390/diagnostics13193073.
P. Shakuntala and V. Sumitra, "Acute Myocarditis," Indian Journal of Practical Pediatrics, vol. 10, no. 2, pp. 65-73, Apr. 2025,
Related Links
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Official website of Assiut University Faculty of Medicine, host institution for this study.
Other Identifiers
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AUMCH-MYO-2025
Identifier Type: -
Identifier Source: org_study_id
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