EpilepsyNCT02415686
Cardiac Arrhythmias in Dravet Syndrome
An observational study of Epilepsy, run by Stichting Epilepsie Instellingen Nederland at 3 sites in 3 countries.
Trial summary
SUMMARY Rationale: People with Dravet Syndrome (DS), a rare epilepsy syndrome, have a high risk of Sudden Unexpected Death in Epilepsy (SUDEP). Mouse models indicated that the responsible sodium channel mutation (SCN1A) not only alters cortical excitability but also increases the propensity to arrhythmias. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Epilepsy
- How many people
- 59 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jun 2015to 29 Aug 2018
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: the Netherlands (coordinating centre: SEIN). Procedure: The UMCU Medical Genetics department is the key referral centre in the Netherlands for DS (Brilstra, UMCU). Cases will be recruited from the UMCU database. Prior to inclusion, a panel (Gunning, Brilstra, Thijs) will review clinical data to ensure diagnostic consistency. Additional DS subjects will be recruited from the local DS databases at Universität Bonn (25 subjects; 4 adults; local coordinator R Surges) and UCL (100 subjects; 15 adults; local coordinator S Sisodiya). We will select historical controls (subjects with epilepsy without DS) from the video-EEG databases of the participating centres.
Criteria:
Cases must meet all of the following criteria:
- DS with a known pathogenic SCN1A mutation
- seizure frequency ≥ 1/week (all seizure types expect for absences or myoclonias)
- no self-harm
- age ≥ 6 years
Each case will be matched to two historical controls (age +/- 5 years). Controls will meet the following criteria:
- definite diagnosis of epilepsy
- no clinical suspicion of DS
- at least two seizures recorded (all seizure types expect for absences or myoclonias) during video-EEG registration.
- age ≥ 6 years
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Netherlands1 site
Stichting Epilepsie Instellingen Nederland (SEIN)
Heemstede, Achterweg 5, 2103 SW
United Kingdom1 site
Great Ormond Street Hospital
London, South East, WC1N 3JH
About this study
Official title: Cardiac Arrhythmias in Dravet Syndrome: an Observational, International, Multicentre Study
SUMMARY
Rationale:
Read more
People with Dravet Syndrome (DS), a rare epilepsy syndrome, have a high risk of Sudden Unexpected Death in Epilepsy (SUDEP). Mouse models indicated that the responsible sodium channel mutation (SCN1A) not only alters cortical excitability but also increases the propensity to arrhythmias. Little is known yet about the prevalence of seizure-induced arrhythmias in human DS subjects.
Objective:
To assess the prevalence of cardiac arrhythmias in DS and to compare the prevalence of cardiac arrhythmias between DS subjects and subjects with other types of epilepsy.
Study design:
Observational study.
Study population:
Subjects with Dravet syndrome and a known pathogenic SCN1A mutation, seizure frequency ≥ 1/week (all seizure types except for absences or myoclonias), age ≥ 6 years and no signs of self-harm. Each case will be matched to two historical controls (age +/- 5 years) from the EEG databases of the participating centres. Only those controls with two or more recorded seizures will be matched to the cases.
Intervention:
Not applicable
Main study parameters/endpoints:
Ictal asystole Ictal bradycardia Ictal QT-shortening/lengthening
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Participation does not carry risks. The sensor is wearable and miniaturised, thus minimising discomfort. If this nevertheless may occur, the study can be terminated. This study provides specific tools to investigate the seizure-related heart rate response. Subjects may thus benefit from participation by identification of otherwise unknown arrhythmias. The rationale of the study (the high SUDEP risk and the evidence in animal studies for arrhythmic cause of sudden death) specifically applies to DS, a rare epileptic syndrome including minors and incapacitated persons. The investigators believe that the lack of risks, the potential diagnostic benefit, the minimal intervention with novel and wearable sensors and the possibility to terminate the study in case of discomfort, justifies the study in this patient group.
- Conditions
- Epilepsy
- Keywords
- Dravet syndrome, Sudden Unexpected Death in Epilepsy (SUDEP), Arrhythmias
- Medical subject headings
- Epilepsy, Epilepsies, Myoclonic, Sudden Unexpected Death in Epilepsy, Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Ictal asystole (sinus arrest ≥ 3 s) or ictal bradycardia (< 2nd heart rate percentile for age)
Measured: We will record heart rate patterns during seizures with miniaturized wearable EKG-monitors for 2 periods of 10 days
Secondary outcomes (1)
Ictal QT lengthening or shortening
Measured: We will record heart rate patterns during seizures with miniaturized wearable EKG-monitors for 2 periods of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startJun 2015
- Primary completion29 Aug 2018
- Study completion29 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stichting Epilepsie Instellingen Nederland
- Sponsor type
- University, hospital or other
- Collaborators
- Epilepsiefonds
- Responsible party
- Sponsor
- Investigators
- Roland Thijs, Dr., Principal investigator, Stichting Epilepsie Instellingen Nederland (S.E.I.N.)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415686
- Sponsor's protocol ID
- NL48765.058.15
- Status last verified
- Nov 2017
- First submitted
- 9 Apr 2015
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Arrhythmias in Dravet Syndrome: an Observational, International, Multicentre Study
- ClinicalTrials.gov ID
- NCT02415686
- Acronym / sponsor ID
- NL48765.058.15
- Conditions
- Epilepsy
- Keywords
- Dravet syndrome, Sudden Unexpected Death in Epilepsy (SUDEP), Arrhythmias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Stichting Epilepsie Instellingen NederlandUniversity, hospital or other
- Collaborators
- Epilepsiefonds
- Study start
- Jun 2015 (actual)
- Primary completion
- 29 Aug 2018 (actual)
- Study completion
- 29 Aug 2018 (actual)
- First posted
- 14 Apr 2015 (estimated)
- 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.
SUMMARY
Rationale:
People with Dravet Syndrome (DS), a rare epilepsy syndrome, have a high risk of Sudden Unexpected Death in Epilepsy (SUDEP). Mouse models indicated that the responsible sodium channel mutation (SCN1A) not only alters cortical excitability but also increases the propensity to arrhythmias. Little is known yet about the prevalence of seizure-induced arrhythmias in human DS subjects.
Objective:
To assess the prevalence of cardiac arrhythmias in DS and to compare the prevalence of cardiac arrhythmias between DS subjects and subjects with other types of epilepsy.
Study design:
Observational study.
Study population:
Subjects with Dravet syndrome and a known pathogenic SCN1A mutation, seizure frequency ≥ 1/week (all seizure types except for absences or myoclonias), age ≥ 6 years and no signs of self-harm. Each case will be matched to two historical controls (age +/- 5 years) from the EEG databases of the participating centres. Only those controls with two or more recorded seizures will be matched to the cases.
Intervention:
Not applicable
Main study parameters/endpoints:
Ictal asystole Ictal bradycardia Ictal QT-shortening/lengthening
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Participation does not carry risks. The sensor is wearable and miniaturised, thus minimising discomfort. If this nevertheless may occur, the study can be terminated. This study provides specific tools to investigate the seizure-related heart rate response. Subjects may thus benefit from participation by identification of otherwise unknown arrhythmias. The rationale of the study (the high SUDEP risk and the evidence in animal studies for arrhythmic cause of sudden death) specifically applies to DS, a rare epileptic syndrome including minors and incapacitated persons. The investigators believe that the lack of risks, the potential diagnostic benefit, the minimal intervention with novel and wearable sensors and the possibility to terminate the study in case of discomfort, justifies the study in this patient group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- the Netherlands (coordinating centre: SEIN). Procedure: The UMCU Medical Genetics department is the key referral centre in the Netherlands for DS (Brilstra, UMCU). Cases will be recruited from the UMCU database. Prior to inclusion, a panel (Gunning, Brilstra, Thijs) will review clinical data to ensure diagnostic consistency. Additional DS subjects will be recruited from the local DS databases at Universität Bonn (25 subjects; 4 adults; local coordinator R Surges) and UCL (100 subjects; 15 adults; local coordinator S Sisodiya). We will select historical controls (subjects with epilepsy without DS) from the video-EEG databases of the participating centres.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ictal asystole (sinus arrest ≥ 3 s) or ictal bradycardia (< 2nd heart rate percentile for age)
Time frame: We will record heart rate patterns during seizures with miniaturized wearable EKG-monitors for 2 periods of 10 days
1 secondary outcome
Ictal QT lengthening or shortening
Time frame: We will record heart rate patterns during seizures with miniaturized wearable EKG-monitors for 2 periods of 10 days
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 7 Sep 2018.
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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.
Roland Thijs, Dr. principal investigator
Stichting Epilepsie Instellingen Nederland (S.E.I.N.)
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Stichting Epilepsie Instellingen Nederland at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Netherlands, United Kingdom. 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?
Ictal asystole (sinus arrest ≥ 3 s) or ictal bradycardia (< 2nd heart rate percentile for age) (time frame: We will record heart rate patterns during seizures with miniaturized wearable EKG-monitors for 2 periods of 10 days). 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 7 Sep 2018.