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MyocarditisPED-MYONCT07175948

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

An observational study of Myocarditis and Myocarditis Acute, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 1 year to 18 years
Conditions the study is for
Myocarditis, Myocarditis Acute
What is being tested?
Standard Medical Therapy
How many people
100 participants
Where
No sites listed yet
Study dates
1 Jun 2026to 1 Aug 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Dr. Elshymaa Abdelmged Abdelmenaem, resident contact

01022507912

alshymabdalmjyd731@gmail.com

About this study

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

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.

Read more

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.

Read the 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.

Being tested
Standard Medical Therapy
Keywords
Viral Myocarditis, Cardiogenic Shock
Medical subject headings
Myocarditis, Shock, Cardiogenic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Medical TherapyOther

    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 TherapyDrug

    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

Study groups in NCT07175948
Study groupRoleWhat they receive
Acute MyocarditisChildren (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.
Receives: Other: Standard Medical Therapy; Drug: Standard Medical Therapy
Fulminant MyocarditisChildren 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.
Receives: Other: Standard Medical Therapy; Drug: Standard Medical Therapy
Chronic Active MyocarditisChildren 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.
Receives: Other: Standard Medical Therapy; Drug: Standard Medical Therapy
Chronic Persistent MyocarditisChildren 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.
Receives: Other: Standard Medical Therapy; Drug: Standard Medical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2025
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07175948
Sponsor's protocol ID
AUMCH-MYO-2025
Acronym
PED-MYO
Status last verified
Sep 2025
First submitted
4 Sep 2025
Last updated
16 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.0000000000000745. Epub 2020 Jan 6.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 37835816
  • P. Shakuntala and V. Sumitra, "Acute Myocarditis," Indian Journal of Practical Pediatrics, vol. 10, no. 2, pp. 65-73, Apr. 2025,

Questions about this trial

What is this clinical trial studying?

An observational study of Myocarditis and Myocarditis Acute, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dr. Elshymaa Abdelmged Abdelmenaem, resident (01022507912, alshymabdalmjyd731@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Classification of clinical phenotypes of myocarditis in children (time frame: At baseline (study enrollment, within first hospital visit).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07175948, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.

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