HEmiplegia Arrhythmia Retrospective Trial

Alternating Hemiplegia of Childhood Clinical Trial

— HEART  

Official title:

Role of Alternating Hemiplegia of Childhood Genotype in Cardiac Repolarization. HEART: HEmiplegia Arrhythmia Retrospective Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04944927
• Other study ID #: 69HCL21_0493
• Status: Completed
• Start date: April 29, 2021
• Est. completion date: June 29, 2022

Study information

• Verified date: February 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Alternating Hemiplegia of Childhood (AHC) is a rare and severe disease that is in need of effective, and hopefully even curative, therapies. Afflicted patients suffer from severe paralyzing crises, often excruciatingly painful muscle spasms, severe often life threatening epileptic seizures, frequently severe developmental and psychiatric/psychological disabilities and other comorbidities, such as cardiac disturbances. Recent data indicate that AHC genotype is in relation to cardiac repolarization troubles and to cardiac arrhythmias. The primary hypothesis to explore is that there is an association between genotype and cardiac phenotype in AHC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 29, 2022
• Est. primary completion date: December 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months and older

Eligibility

Inclusion Criteria:

• Patients that meet the clinical diagnostic criteria (Aicardi et al, 1995) for typical alternating hemiplegia with or without identified mutations in ATP1A3.

• At least one ECG study is required.

• Patients ages yearand more

Exclusion Criteria:

• Informed consent or assent not obtainable

• ATP1A3 testing not performed

• No ECG studies are available

Related Conditions & MeSH terms

• Alternating Hemiplegia of Childhood
• Arrhythmias, Cardiac
• Hemiplegia

Intervention

Other:
• Recording of clinical parameters and electrocardiogram parameters
Retrospective recording of demographic information (age, sex, age at diagnosis), genetic information, cardiological information, pharmacological treatments, electrocardiogram data. All above data will be deidentified.

Locations

Country	Name	City	State
France	Department of Clinical Epileptology, Sleep Disorders and Functional Neurology in Children, Hôpital Femme Mère Enfant, University Hospitals of Lyon (Hospices Civils de Lyon)	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of QTc interval and all relevant cardiac repolarization measurements	Outcome measure: QTc interval and cardiac repolarization measurement in milliseconds.	Day 1