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NCT Number: NCT07842705

Myocardial Changes in Pediatric Guillain-Barré Syndrome

This prospective cohort study aims to identify and characterize cardiac changes including electrocardiographic, echocardiographic, and biochemical abnormalities in pediatric patients with Guillain-Barré syndrome.

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Key information

Conditions

Myocardial Dysfunction Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Diseases Disease Attributes Guillain-Barre Syndrome Immune System Diseases Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Post-Infectious Disorders

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

Guillain-Barré syndrome can be associated with cardiac autonomic dysfunction and myocardial involvement. This observational study will include pediatric patients (1 month to 18 years) with confirmed Guillain-Barré syndrome.

Participants will undergo electrocardiography, echocardiography, and cardiac biomarker assessment at hospital admission and at 3-month follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 1 month to 18 years
  • Confirmed diagnosis of Guillain-Barré syndrome
  • Onset of neurological symptoms within 2 weeks prior to hospital presentation
  • No pre-existing cardiac disease
  • Written informed consent from parents or legal guardians

Exclusion criteria

  • Pre-existing congenital or acquired heart disease
  • Pre-existing neuromuscular disorders or hereditary peripheral neuropathies
  • Incomplete cardiac workup (inability to perform ECG, echocardiography, and cardiac biomarker assessment)
  • Loss to follow-up before hospital discharge

Treatment and study plan

Primary outcomes

  1. Prevalence of cardiac abnormalities

    Time frame: Baseline

    Proportion of patients with any cardiac abnormality detected by electrocardiography, echocardiography, or elevated cardiac biomarkers (troponin I or CK-MB).

Secondary outcomes

  1. Prevalence of electrocardiographic abnormalities

    Time frame: Baseline

    Proportion of patients with ECG abnormalities including rhythm disturbances, ST-segment changes, T-wave abnormalities, or conduction blocks.

  2. Mean left ventricular ejection fraction (LVEF)

    Time frame: Baseline

    Mean left ventricular ejection fraction percentage measured by echocardiography.

  3. Prevalence of elevated cardiac troponin I

    Time frame: Baseline

    Proportion of patients with elevated serum cardiac troponin I levels.

  4. Prevalence of cardiac abnormalities at follow-up

    Time frame: At 3 months

    Proportion of patients with any cardiac abnormality detected by electrocardiography, echocardiography, or elevated cardiac biomarkers at 3-month follow-up.

  5. Mean left ventricular ejection fraction at follow-up

    Time frame: At 3 months

    Mean left ventricular ejection fraction percentage measured by echocardiography at 3-month follow-up.

Interested in participating?

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Trial opening soon.

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Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Myocardial Changes in Pediatric Patients With Guillain-Barré Syndrome

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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