HEmiplegia Arrhythmia Retrospective Trial

NCT ID: NCT04944927

Last Updated: 2023-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-29

Study Completion Date

2022-06-29

Brief Summary

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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.

Detailed Description

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Conditions

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Alternating Hemiplegia of Childhood

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with Alternating Hemiplegia of Childhood

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 prolonged ECG study available is required.

Recording of clinical parameters and electrocardiogram parameters

Intervention Type OTHER

Retrospective recording of demographic information (age, sex, age at diagnosis), genetic information, cardiological information, pharmacological treatments, electrocardiogram data. All above data will be deidentified.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Bron, , France

Site Status

Countries

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France

Other Identifiers

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69HCL21_0493

Identifier Type: -

Identifier Source: org_study_id

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