- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04944927
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 Contact
- Name: Eleni PANAGIOTAKAKI, MD
- Phone Number: +33 4 27 85 60 60
- Email: eleni.panagiotakaki@chu-lyon.fr
Study Locations
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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)
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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. |
Retrospective recording of demographic information (age, sex, age at diagnosis), genetic information, cardiological information, pharmacological treatments, electrocardiogram data.
All above data will be deidentified.
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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
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Outcome measure: QTc interval and cardiac repolarization measurement in milliseconds.
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Day 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
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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