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NCT Number: NCT01946776

Cardiac Arrhythmias in Epilepsy: the CARELINK-study

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).

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Key information

Conditions

Epilepsy Arrhythmias, Cardiac Asystole Brain Diseases Cardiac Arrhythmias Cardiovascular Diseases Central Nervous System Diseases Heart Arrest Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Medical Center, Heerlen, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

implantable heart rate monitor

Device

Implantation of Reveal XT

Other names: Reveal XT

Primary outcomes

  1. 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:

    • 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.
    • Asystole of ≥10s regardless of report of clinical symptoms
    • Other cardiac arrhythmias of clinical significance:
    • polymorphic sustained or non-sustained ventricular tachycardia (VT)
    • non-sustained monomorphic VT of >180 bpm and >2s duration, or >175 bpm and >3s duration, and sustained monomorphic VT
    • atrial fibrillation (AF) of >200 bpm and >30s duration, or <55 bpm and clinical symptoms (dizziness or dyspnea)
    • persistent sinus bradycardia of <40 bpm during physical activity
    • asymptomatic 2nd or 3rd degree atrioventricular (AV) block of >4s duration

Secondary outcomes

  1. 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.

Other outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Stichting Epilepsie Instellingen Nederland

Other

Collaborators

  • Fonds NutsOhra
  • Medtronic

Registry information

Official study title

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

Acronym: CARELINK

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 20, 2013
Registry last updated
Dec 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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