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OpenTrials
Completed

NCT Number: NCT04944927

HEmiplegia Arrhythmia Retrospective Trial

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.

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Key information

Age range

12 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Bron, 69677, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Recording of clinical parameters and electrocardiogram parameters

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.

Primary outcomes

  1. Measurement of QTc interval and all relevant cardiac repolarization measurements

    Time frame: Day 1

    Outcome measure: QTc interval and cardiac repolarization measurement in milliseconds.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: HEART

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jun 30, 2021
Registry last updated
Feb 22, 2023

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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