HEmiplegia Arrhythmia Retrospective Trial

NCT04944927 | Completed

• 1 other identifier: 69HCL21_0493
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alternating Hemiplegia of Childhood

Keywords

QTc; Cardiac repolarization and arrhythmia; ECG; Alternating Hemiplegia

Outcome Measures

Primary Outcomes (1)

• Measurement of QTc interval and all relevant cardiac repolarization measurements

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

  Day 1

Study Arms (1)

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.

Other: Recording of clinical parameters and electrocardiogram parameters

Interventions

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.

Patients with Alternating Hemiplegia of Childhood

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Alternating Hemiplegia of Childhood

You may qualify if:

• 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

You may not qualify if:

• Informed consent or assent not obtainable
• ATP1A3 testing not performed
• No ECG studies are available

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Location

MeSH Terms

Conditions

Alternating hemiplegia of childhood; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 30, 2021
• Study Start: April 29, 2021
• Primary Completion: December 29, 2021
• Study Completion: June 29, 2022
• Last Updated: February 22, 2023

Record last verified: 2023-02

Locations

FR (1)