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EpilepsyCARELINKNCT01946776

Cardiac Arrhythmias in Epilepsy: the CARELINK-study

A study testing implantable heart rate monitor in people with Epilepsy and Asystole, run by Stichting Epilepsie Instellingen Nederland at 4 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients with difficult-to-treat epilepsy ("refractory epilepsy") are at high risk of sudden death: sudden unexpected death in epilepsy (SUDEP). Cardiac arrhythmias are one of the possible causes of SUDEP. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Epilepsy, Asystole, Cardiac Arrhythmias
What is being tested?
implantable heart rate monitor
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
4 sitesNetherlands
Study dates
Jun 2013to Dec 2016
Phase
Interventional
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Drug-resistant focal epilepsy: failure of adequate trials of two tolerated and appropriately chosen and used antiepileptic drug (AED) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom [16]
  • ≥ 1 complex partial and/or generalized tonic clonic seizure/month as indicated by history taking
  • If female, not pregnant
  • Aged 18 to 60 years
  • Able to undergo the study procedure as judged by the treating physician.

Who cannot join

  • Clinical suspicion of seizure-induced asystole (e.g. seizures with sudden flaccid falls)
  • Reveal implantation (either present or in the past)
  • Known clinical relevant structural cardiac disease
  • Hereditary syndromes that increase the risk of cardiomyopathy (e.g. Marfan's disease)
  • ECG findings suggestive of arrhythmias without proper cardiac evaluation to in- or exclude this possibility. According to European Society of Cardiology (ESC) guidelines on syncope the following ECG findings will be used: bifascicular block and other intraventricular conduction abnormalities, asymptomatic inappropriate sinus bradycardia (<50 bpm), sinoatrial block or sinus pause ≥3s in the absence of negative chronotropic medications, non-sustained VT, pre-exited QRS complexes, prolonged or short QT interval, Brugada pattern, pattern suggestive of arrhythmogenic right ventricular cardiomyopathy.
  • Pacemaker
Show all 9Show fewer
  • Use of beta blockers or other anti-arrhythmic/anti-arrhythmogenic medication
  • Previous diagnosis of psychogenic non-epileptic seizures
  • Patients who live alone and are not able to recall their seizures

Trial locations and contacts

4 sites in 1 country.

Netherlands4 sites

  • Atrium Medical Center

    Heerlen

  • Epilepsy center Kempenhaeghe

    Heeze

  • Epilepsy Instititute in the Netherlands Foundation (SEIN)

    Hoofddorp, 2130 AM

  • Antonius Hospital

    Sneek

Other trials in Netherlands

About this study

Official title: Cardiac Arrhythmias in Refractory Epilepsy: Identifying Prevalence and LINKage Between Seizures and Arrhythmias

Patients with difficult-to-treat epilepsy ("refractory epilepsy") are at high risk of sudden death: sudden unexpected death in epilepsy (SUDEP). Cardiac arrhythmias are one of the possible causes of SUDEP. When monitoring in the hospital setting, the frequency of cardiac arrhythmias in people with epilepsy is low: 0,4%. However, when a subcutaneous implantable device (Reveal XT) is used to monitor heart rhythm continuously for an extended period of time, the frequency of clinically relevant arrhythmias appeared much higher in two small observational studies (n=19): 6-20%. The aim of this study is to analyze the frequency and underlying mechanism of cardiac arrhythmias in a larger group of 50 people with refractory epilepsy with Reveal XT. In the future, this may help us to identify those epilepsy patients at high risk of cardiac arrhythmias, so that we can timely institute preventive measures (e.g. pacemaker implantation).

Being tested
implantable heart rate monitor
Medical subject headings
Epilepsy, Heart Arrest, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • implantable heart rate monitorDevice

    Also called Reveal XT

    Implantation of Reveal XT

Study groups in NCT01946776
Study groupRoleWhat they receive
Reveal XTOtherPeople with drug-resistant epilepsy whose heart rhythm will be monitored continuously for 2 years using Reveal XT, an implantable heart rate monitor.
Receives: Device: implantable heart rate monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and two-year prevalence of clinically relevant cardiac arrhythmia.

    Clinical relevant cardiac arrhythmia is defined as:

    1. Asystole of ≥ 6s together with clinical symptoms (lightheadedness, syncope, seizure) as indicated by seizure diary, activation of the portable seizure monitor, or patient activation of Reveal XT. The time frame between the reported clinical symptoms and the recorded event should not exceed 15 minutes.
    2. Asystole of ≥10s regardless of report of clinical symptoms
    3. Other cardiac arrhythmias of clinical significance:
    4. polymorphic sustained or non-sustained ventricular tachycardia (VT)
    5. non-sustained monomorphic VT of >180 bpm and >2s duration, or >175 bpm and >3s duration, and sustained monomorphic VT
    6. atrial fibrillation (AF) of >200 bpm and >30s duration, or <55 bpm and clinical symptoms (dizziness or dyspnea)
    7. persistent sinus bradycardia of <40 bpm during physical activity
    8. asymptomatic 2nd or 3rd degree atrioventricular (AV) block of >4s duration

    Measured: Continuously for two years or until the end-of-battery-life of Reveal XT (this period is expected to last an additional six months on average)

Secondary outcomes (1)

  1. the number of patients who will have received a permanent pacemaker at the end of this study.

    Participants who will exhibit a clinically relevant arrhythmia (see our primary endpoints) during this study will be referred to an independent cardiologist for further evaluation and/or treatment. In a certain number of cases, this cardiologist will decide with the patient that pacemaker implantation would be the appropriate cause of action.

    Measured: Continuously for two years or until the end-of-battery-life of Reveal XT (this period is expected to last an additional six months on average)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01946776
Sponsor's protocol ID
1201-071
Acronym
CARELINK
Status last verified
Dec 2016
First submitted
29 Aug 2013
Last updated
26 Dec 2016
Results posted
No
Data monitoring committee
No

Publications

  • Surges R, Thijs RD, Tan HL, Sander JW. Sudden unexpected death in epilepsy: risk factors and potential pathomechanisms. Nat Rev Neurol. 2009 Sep;5(9):492-504. doi: 10.1038/nrneurol.2009.118. Epub 2009 Aug 11.

    PubMed 19668244

  • Schuele SU, Bermeo AC, Alexopoulos AV, Locatelli ER, Burgess RC, Dinner DS, Foldvary-Schaefer N. Video-electrographic and clinical features in patients with ictal asystole. Neurology. 2007 Jul 31;69(5):434-41. doi: 10.1212/01.wnl.0000266595.77885.7f.

    PubMed 17664402

  • Rugg-Gunn FJ, Simister RJ, Squirrell M, Holdright DR, Duncan JS. Cardiac arrhythmias in focal epilepsy: a prospective long-term study. Lancet. 2004 Dec 18-31;364(9452):2212-9. doi: 10.1016/S0140-6736(04)17594-6.

    PubMed 15610808

  • Nei M, Sperling MR, Mintzer S, Ho RT. Long-term cardiac rhythm and repolarization abnormalities in refractory focal and generalized epilepsy. Epilepsia. 2012 Aug;53(8):e137-40. doi: 10.1111/j.1528-1167.2012.03561.x. Epub 2012 Jun 18.

    PubMed 22709423

  • Sevcencu C, Struijk JJ. Autonomic alterations and cardiac changes in epilepsy. Epilepsia. 2010 May;51(5):725-37. doi: 10.1111/j.1528-1167.2009.02479.x. Epub 2010 Jan 7.

    PubMed 20067509

Questions about this trial

What is this clinical trial studying?

A study testing implantable heart rate monitor in people with Epilepsy and Asystole, run by Stichting Epilepsie Instellingen Nederland at 4 sites in Netherlands.

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 5 inclusion and 9 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 26 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Netherlands. 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?

Incidence and two-year prevalence of clinically relevant cardiac arrhythmia. (time frame: Continuously for two years or until the end-of-battery-life of Reveal XT (this period is expected to last an additional six months on average)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01946776, which also lists 5 linked publications.

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 26 Dec 2016.

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