Alternating Hemiplegia of ChildhoodHEARTNCT04944927
HEmiplegia Arrhythmia Retrospective Trial
An observational study of Alternating Hemiplegia of Childhood, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 months and older
- Conditions the study is for
- Alternating Hemiplegia of Childhood
- What is being tested?
- Recording of clinical parameters and electrocardiogram parameters
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 29 Apr 2021to 29 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Alternating Hemiplegia of Childhood
Who may be able to join
- 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
Who cannot join
- Informed consent or assent not obtainable
- ATP1A3 testing not performed
- No ECG studies are available
Trial locations and contacts
1 site in 1 country.
France1 site
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
About this study
Official title: 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.
- Conditions
- Alternating Hemiplegia of Childhood
- Being tested
- Recording of clinical parameters and electrocardiogram parameters
- Keywords
- QTc, Cardiac repolarization and arrhythmia, ECG, Alternating Hemiplegia
- Medical subject headings
- Alternating hemiplegia of childhood, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recording of clinical parameters and electrocardiogram parametersOther
Retrospective recording of demographic information (age, sex, age at diagnosis), genetic information, cardiological information, pharmacological treatments, electrocardiogram data. All above data will be deidentified.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Recording of clinical parameters and electrocardiogram parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of QTc interval and all relevant cardiac repolarization measurements
Outcome measure: QTc interval and cardiac repolarization measurement in milliseconds.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start29 Apr 2021
- Primary completion29 Dec 2021
- Study completion29 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alternating Hemiplegia of ChildhoodStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944927
- Sponsor's protocol ID
- 69HCL21_0493
- Acronym
- HEART
- Status last verified
- Feb 2023
- First submitted
- 2 Jun 2021
- Last updated
- 22 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Alternating Hemiplegia of Childhood Genotype in Cardiac Repolarization. HEART: HEmiplegia Arrhythmia Retrospective Trial
- ClinicalTrials.gov ID
- NCT04944927
- Acronym / sponsor ID
- HEART / 69HCL21_0493
- Conditions
- Alternating Hemiplegia of Childhood
- Keywords
- QTc, Cardiac repolarization and arrhythmia, ECG, Alternating Hemiplegia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 29 Dec 2021 (actual)
- Study completion
- 29 Jun 2022 (actual)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Alternating Hemiplegia of Childhood | – | Other: Recording of clinical parameters and electrocardiogram parametersPatients 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. |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Alternating Hemiplegia of Childhood
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Informed consent or assent not obtainable
- ATP1A3 testing not performed
- No ECG studies are available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recording of clinical parameters and electrocardiogram parametersRetrospective recording of demographic information (age, sex, age at diagnosis), genetic information, cardiological information, pharmacological treatments, electrocardiogram data. All above data will be deidentified. | Other | Patients with Alternating Hemiplegia of Childhood |
Primary outcome
Measurement of QTc interval and all relevant cardiac repolarization measurements
Time frame: Day 1
Outcome measure: QTc interval and cardiac repolarization measurement in milliseconds.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alternating Hemiplegia of Childhood, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of QTc interval and all relevant cardiac repolarization measurements (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.