Cardiac arrhythmias in Dravet syndrome (CADS) Version 1
Research type
Research Study
Full title
Cardiac arrhythmias in Dravet syndrome: an observational, international, multicentre study
IRAS ID
199175
Contact name
Helen Cross
Contact email
Sponsor organisation
Stichting Epilepsie Instellingen Nederland (SEIN)
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
No Z6364106/2016/10/24, UCL Data Protection Registration; NL48765.058.15, Commissie Medishe Ethiek Approval #; P15.017, METC #; 16NC32, GOSH / ICH JRO Ref #
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
People with Dravet Syndrome (DS) 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.
We will assess the prevalence of cardiac arrhythmias in DS and compare this with subjects with other types of epilepsy.
All participants will have a baseline 12-lead ECG, at the outpatient clinic of the hospital/institution where their epilepsy care is based. They will then wear an ambulatory, home-based, sensor for 2 periods of 10-days.
This study provides specific tools to investigate the seizure-related heart rate response. Participants may thus benefit from participation by identification of otherwise unknown arrhythmias.REC name
Wales REC 4
REC reference
17/WA/0025
Date of REC Opinion
7 Mar 2017
REC opinion
Further Information Favourable Opinion