HEmiplegia Arrhythmia Retrospective Trial (HEART)

February 20, 2023 updated by: Hospices Civils de Lyon

Role of Alternating Hemiplegia of Childhood Genotype in Cardiac Repolarization. HEART: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69677
        • Department of Clinical Epileptology, Sleep Disorders and Functional Neurology in Children, Hôpital Femme Mère Enfant, University Hospitals of Lyon (Hospices Civils de Lyon)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Alternating Hemiplegia of Childhood

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of QTc interval and all relevant cardiac repolarization measurements
Time Frame: Day 1
Outcome measure: QTc interval and cardiac repolarization measurement in milliseconds.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2021

Primary Completion (Actual)

December 29, 2021

Study Completion (Actual)

June 29, 2022

Study Registration Dates

First Submitted

June 2, 2021

First Submitted That Met QC Criteria

June 21, 2021

First Posted (Actual)

June 30, 2021

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 20, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL21_0493

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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