CompletedNot Applicable

Cardiac Arrhythmias in Dravet Syndrome

Germany, Netherlands, United Kingdom59 participantsStarted 2015-06

Plain-language 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. 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.

Who can participate

Age range

6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Criteria: Cases must meet all of the following criteria: 1. DS with a known pathogenic SCN1A mutation 2. seizure frequency ≥ 1/week (all seizure types expect for absences or myoclonias) 3. no self-harm 4. age ≥ 6 years Each case will be matched to two historical controls (age +/- 5 years). Controls will meet the following criteria: 1. definite diagnosis of epilepsy 2. no clinical suspicion of DS 3. at least two seizures recorded (all seizure types expect for absences or myoclonias) during video-EEG registration. 4. age ≥ 6 years

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial specifically looked for dangerous heart rhythm changes — like the heart pausing for 3 seconds or more — during seizures in Dravet syndrome. Did my child's evaluation include any monitoring for these kinds of cardiac events, or is that something we should discuss testing for?
2Since this study has already been completed, has my doctor seen the results, and do those findings change how they would monitor my child's heart during seizures going forward?
3The trial focused on Dravet syndrome and epilepsy together with cardiac risks — given that my child has Dravet syndrome, should we be working with a cardiologist alongside the neurologist to watch for these arrhythmias?
4Because this was listed as phase 'NA,' it sounds more like an observational study than a treatment trial — does that mean it was gathering safety information rather than testing a therapy, and are there any treatment trials my doctor would recommend based on what studies like this have found?
5If ictal bradycardia or heart pauses are a real risk in Dravet syndrome, are there specific precautions — like emergency protocols, implantable devices, or medication adjustments — that my doctor thinks we should consider given these findings?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ictal asystole (sinus arrest ≥ 3 s) or ictal bradycardia (< 2nd heart rate percentile for age)

Timeframe: We will record heart rate patterns during seizures with miniaturized wearable EKG-monitors for 2 periods of 10 days

Trial details

NCT IDNCT02415686

SponsorStichting Epilepsie Instellingen Nederland

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-08-29

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