Cardiac Arrhythmias in Epilepsy: the CARELINK-study (CARELINK)

December 23, 2016 updated by: Stichting Epilepsie Instellingen Nederland

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Heerlen, Netherlands
        • Atrium Medical Center
      • Heeze, Netherlands
        • Epilepsy center Kempenhaeghe
      • Hoofddorp, Netherlands, 2130 AM
        • Epilepsy Instititute in the Netherlands Foundation (SEIN)
      • Sneek, Netherlands
        • Antonius Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Reveal XT
People with drug-resistant epilepsy whose heart rhythm will be monitored continuously for 2 years using Reveal XT, an implantable heart rate monitor.
Device: implantable heart rate monitor
Implantation of Reveal XT
Other Names:
  • Reveal XT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)

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:

    1. polymorphic sustained or non-sustained ventricular tachycardia (VT)
    2. non-sustained monomorphic VT of >180 bpm and >2s duration, or >175 bpm and >3s duration, and sustained monomorphic VT
    3. atrial fibrillation (AF) of >200 bpm and >30s duration, or <55 bpm and clinical symptoms (dizziness or dyspnea)
    4. persistent sinus bradycardia of <40 bpm during physical activity
    5. asymptomatic 2nd or 3rd degree atrioventricular (AV) block of >4s duration
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
the number of patients who will have received a permanent pacemaker at the end of this study.
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)
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.
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of seizure-related cardiac arrhythmias
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)
The number of seizures during which a cardiac arrhythmia occurs divided by the total number of seizures during this study
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)
The percentage of patients with a cardioinhibitory response to head-up tilt-testing
Time Frame: During one head-up tilt-test (approximate duration 1,5 hours)
The number of patients with a cardioinhibitory response to head-up tilt-testing (1) heart rate rising initially then falling to a ventricular rate of <40 bpm for >10 seconds or asystole occurring for >3 seconds, with blood pressure rising initially then falling before the heart rate falls 2) Heart rate rising initially then falling to a ventricular rate <40 bpm for >10 seconds or asystole occurring for >3 seconds, with blood pressure rising initially and only falling to hypotensive levels <80 mm Hg systolic at or after the onset of rapid and severe heart rate fall) divided by the number of patients in whom tilt-testing was performed.
During one head-up tilt-test (approximate duration 1,5 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stichting Epilepsie Instellingen Nederland

Collaborators

Medtronic
Fonds NutsOhra

Investigators

  • Principal Investigator: Roland D Thijs, PhD, SEIN-Epilepsy Institute in the Netherlands Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 29, 2013

First Submitted That Met QC Criteria

September 16, 2013

First Posted (Estimate)

September 20, 2013

Study Record Updates

Last Update Posted (Estimate)

December 26, 2016

Last Update Submitted That Met QC Criteria

December 23, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1201-071

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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