Outcome of Clinical Phenotypes of Pediatric Myocarditis at Assiut University Children Hospital

Official title

Outcome of Different Clinical Phenotypes of Myocarditis in Children Admitted to Assiut University Children Hospital

Overview

This study aims to investigate the clinical phenotypes, management approaches, and outcomes of myocarditis in children admitted to Assiut University Children's Hospital. Myocarditis is an inflammatory disease of the heart muscle that can present in different clinical forms, including acute, fulminant, chronic active, and chronic persistent types. These forms vary in severity, treatment needs, and long-term outcomes. 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.

Detailed description

Myocarditis is an inflammatory disorder of the myocardium that may cause myocyte injury, necrosis, and cardiac dysfunction. Pediatric myocarditis has heterogeneous clinical phenotypes, commonly categorized into acute, fulminant, chronic active, and chronic persistent forms. These categories differ in pathophysiology, clinical presentation, and prognosis, making phenotypic classification essential for guiding treatment decisions and predicting outcomes.

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.

Interventions

• Other 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.
• Drug 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

Primary outcome measures

• Classification of clinical phenotypes of myocarditis in children [Time frame: At baseline (study enrollment, within first hospital visit).]
• Classification of clinical phenotypes of myocarditis in children [Time frame: At baseline (upon parental enrollment, assessed once at study start).]

Eligibility criteria

Inclusion criteria

• • Children aged between 1 to 18 years.

• Children diagnosed with myocarditis based on clinical presentation, echocardiography, and cardiac biomarkers, ECG and MRI (if available)

Exclusion criteria

• • Children with congenital heart disease.

• Known cardiomyopathy unrelated to myocarditis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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. PMID 36915162
• 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. PMID 30850001
• 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.00000000000 PMID 31902242
• 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. PMID 35928042
• 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. PMID 26699389
• 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
• 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. PMID 37835816
• P. Shakuntala and V. Sumitra, "Acute Myocarditis," Indian Journal of Practical Pediatrics, vol. 10, no. 2, pp. 65-73, Apr. 2025,

Identifiers

NCT: NCT07175948 · AUMCH-MYO-2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗