Outcome of Clinical Phenotypes of Pediatric Myocarditis at Assiut University Children Hospital
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• Children aged between 1 to 18 years.
Children diagnosed with myocarditis based on clinical presentation, echocardiography, and cardiac biomarkers, ECG and MRI (if available)
Disqualifiers
• Children with congenital heart disease.
Known cardiomyopathy unrelated to myocarditis.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Standard Medical Therapy
Other interventionAll 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
DrugAll 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
Treatment groups
100 Participants
are divided into 4 treatment groupsGroup A: Acute Myocarditis2 interventions
Group B: Fulminant Myocarditis2 interventions
Group C: Chronic Active Myocarditis2 interventions
Group D: Chronic Persistent Myocarditis2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
At baseline (study enrollment, within first hospital visit).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.
Time frame
At baseline (upon parental enrollment, assessed once at study start).Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: