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

NCT07175948 | Not Yet Recruiting

• 1 other identifier: AUMCH-MYO-2025
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Myocarditis; Myocarditis Acute

Keywords

Viral Myocarditis; Cardiogenic Shock

Outcome Measures

Primary Outcomes (2)

• Classification of clinical phenotypes of myocarditis in children

  Phenotypic classification (acute, fulminant, chronic active, chronic persistent) will be assigned based on clinical presentation, echocardiography, cardiac biomarkers, and ECG/MRI findings.

  At baseline (study enrollment, within first hospital visit).

• Classification of clinical phenotypes of myocarditis in children

  Phenotypic classification (acute, fulminant, chronic active, chronic persistent) will be assigned based on clinical presentation, echocardiography, cardiac biomarkers, and ECG/MRI findings.

  At baseline (upon parental enrollment, assessed once at study start).

Study Arms (4)

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.

Other: Standard Medical Therapy; Drug: Standard Medical Therapy

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.

Other: Standard Medical Therapy; Drug: Standard Medical Therapy

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.

Other: Standard Medical Therapy; Drug: Standard Medical Therapy

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.

Other: Standard Medical Therapy; Drug: Standard Medical Therapy

Interventions

Standard Medical Therapy OTHER

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.

Acute Myocarditis; Chronic Active Myocarditis; Chronic Persistent Myocarditis; Fulminant Myocarditis

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All available patients diagnosed with myocarditis and attending Assiut University children hospital during the study period will be included in this study All patients included in the study will have fulfilled the established criteria to ensure the appropriateness and consistency of the study population.

You may qualify if:

• Children aged between 1 to 18 years.
• Children diagnosed with myocarditis based on clinical presentation, echocardiography, and cardiac biomarkers, ECG and MRI (if available)

You may not qualify if:

• Children with congenital heart disease.
• Known cardiomyopathy unrelated to myocarditis.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 31902242 BACKGROUND

• 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 BACKGROUND

• 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 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

• 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 BACKGROUND

• P. Shakuntala and V. Sumitra, "Acute Myocarditis," Indian Journal of Practical Pediatrics, vol. 10, no. 2, pp. 65-73, Apr. 2025,

  BACKGROUND

Related Links

• Official website of Assiut University Faculty of Medicine, host institution for this study.

MeSH Terms

Conditions

Myocarditis; Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Myocardial Infarction; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Central Study Contacts

Dr. Elshymaa Abdelmged Abdelmenaem, resident

CONTACT

01022507912; alshymabdalmjyd731@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident , pediatric department

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 16, 2025
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share