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临床试验/NCT07175948
NCT07175948尚未招募不适用

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

Assiut University0 个研究点目标入组 100 人开始时间: 2026年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Classification of clinical phenotypes of myocarditis in children

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

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.

干预措施: Standard Medical Therapy (Drug)

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.

干预措施: Standard Medical Therapy (Drug)

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.

干预措施: Standard Medical Therapy (Drug)

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.

干预措施: Standard Medical Therapy (Drug)

结局指标

主要结局

Classification of clinical phenotypes of myocarditis in children

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

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elshymaa Abdelmged Abdelmenaem

resident , pediatric department

Assiut University

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