Myocardial DysfunctionNCT07842705
Myocardial Changes in Pediatric Guillain-Barré Syndrome
An observational study of Myocardial Dysfunction and Guillain-Barre Syndrome, run by Assiut University.
Trial summary
This prospective cohort study aims to identify and characterize cardiac changes including electrocardiographic, echocardiographic, and biochemical abnormalities in pediatric patients with Guillain-Barré syndrome. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Myocardial Dysfunction, Guillain-Barre Syndrome
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 26 Sep 2026to 25 Jan 2028
- Phase
- Observational
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 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients aged 1 month to 18 years with confirmed Guillain-Barré syndrome admitted to Assiut University Children's Hospital.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Myocardial Changes in Pediatric Patients With 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.
Read the detailed description
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.
- Conditions
- Myocardial Dysfunction, Guillain-Barre Syndrome
- Keywords
- Guillain-Barré syndrome, Assiut, ECG, Echocardiography, Myocardial changes, Pediatric
- Medical subject headings
- Guillain-Barre Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single cohort: Pediatric patients with Guillain-Barré syndrome | Pediatric patients with confirmed Guillain-Barré syndrome who will undergo cardiac evaluation at admission and at 3-month follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of cardiac abnormalities
Proportion of patients with any cardiac abnormality detected by electrocardiography, echocardiography, or elevated cardiac biomarkers (troponin I or CK-MB).
Measured: Baseline
Secondary outcomes (5)
Prevalence of electrocardiographic abnormalities
Proportion of patients with ECG abnormalities including rhythm disturbances, ST-segment changes, T-wave abnormalities, or conduction blocks.
Measured: Baseline
Mean left ventricular ejection fraction (LVEF)
Mean left ventricular ejection fraction percentage measured by echocardiography.
Measured: Baseline
Prevalence of elevated cardiac troponin I
Proportion of patients with elevated serum cardiac troponin I levels.
Measured: Baseline
Prevalence of cardiac abnormalities at follow-up
Proportion of patients with any cardiac abnormality detected by electrocardiography, echocardiography, or elevated cardiac biomarkers at 3-month follow-up.
Measured: At 3 months
Mean left ventricular ejection fraction at follow-up
Mean left ventricular ejection fraction percentage measured by echocardiography at 3-month follow-up.
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start26 Sep 2026 (estimated)
- Primary completion26 Sep 2027 (estimated)
- Study completion25 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial DysfunctionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Magdy Monir, Assiut University
- Investigators
- Faisal A Ahmed, prof, Study chair, Pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842705
- Sponsor's protocol ID
- GBS-Cardiac-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No