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Completed

NCT Number: NCT03376087

Cardiac Rhythm Disturbances in Hard-to-treat Epilepsy Patients Using Loop ECG Recorders

Seizure-related cardiac arrhythmias are one of the possible causes of sudden unexpected death in epilepsy (SUDEP). Identification of these patients is challenging because cardiac rhythm disturbances could emerge only during seizures. Furthermore, patients could have transitioned sinus or AV node blocks which could cause syncopes with brady-related seizures which could be treated as epilepsy-related seizures. Implantable loop recorders have an ability to recording single-channel ECG for up to 36 months which give an ability to detect these heart disturbances.

The purpose of this study is to look the incidence and types of arrhythmias which occur in 150 patients with hard-to-treat partial seizures and secondarily generalized seizures

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Key information

Conditions

Epilepsy Arrhythmias, Cardiac Brain Diseases Cardiac Conduction System Disease Cardiovascular Diseases Central Nervous System Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Block Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hard-to-treat focal epilepsy
  • Aged 18 to 60 years
  • If female not pregnant

Exclusion criteria

  • Known clinical relevant structural cardiac disease
  • Implanted pacemaker, including cardiac resynchronisation device, or defibrillator
  • Use of beta blockers or other antiarrhythmic medication
  • Diagnosis of psychogenic non-epileptic seizures

Treatment and study plan

Primary outcomes

  1. Identification of a dysrhythmia

    Time frame: 3 years or until the end-of-battery life of Reveal XT, whichever came first

    A dysrhythmia will be defined as either

    • asystole of ≥6 s
    • sinus bradycardia of ≤40 bpm during physical activity
    • 2nd or 3rd-degree AV-block
    • sinus tachycardia of ≥120 bpm
    • nonsustained and sustained monomorphic VT of ≥170 bpm
    • polymorphic VT
    • atrial fibrillation/flutter

Secondary outcomes

  1. The number of patients who will have receive the permanent pacemaker at the end of the study.

    Time frame: 3 years or until the end-of-battery life of Reveal XT, whichever came first

Sponsors and collaborators

Lead sponsor

National Research Center for Preventive Medicine

Other Gov

Collaborators

  • Pirogov Russian National Research Medical University

Registry information

Acronym: Epi-Loop-Rec

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 18, 2017
Registry last updated
Dec 7, 2020

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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