Cardiac Rhythm Disturbances in Hard-to-treat Epilepsy Patients Using Loop ECG Recorders (Epi-Loop-Rec)

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

Study Overview

• Status: Completed
• Conditions: Epilepsy

• Study Type: Observational
• Enrollment (Actual): 193

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with hard-to-treat epilepsy without known cardiac disease and beta-blockers therapy

Description

Inclusion Criteria:

1. Hard-to-treat focal epilepsy
2. Aged 18 to 60 years
3. If female not pregnant

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of a dysrhythmia	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	3 years or until the end-of-battery life of Reveal XT, whichever came first

Secondary Outcome Measures

Outcome Measure	Time Frame
The number of patients who will have receive the permanent pacemaker at the end of the study.	3 years or until the end-of-battery life of Reveal XT, whichever came first

Collaborators and Investigators

• Sponsor: National Research Center for Preventive Medicine
• Collaborators: Pirogov Russian National Research Medical University

Publications and helpful links

General Publications

• Serdyuk S, Davtyan K, Burd S, Teryan R, Kharlap M, Drapkina O. A case of sudden unexpected death of a patient with epilepsy: Continuous electrocardiographic monitoring and autopsy results. HeartRhythm Case Rep. 2018 Nov 30;5(3):138-142. doi: 10.1016/j.hrcr.2018.11.014. eCollection 2019 Mar. No abstract available.
• Serdyuk S, Davtyan K, Burd S, Drapkina O, Boytsov S, Gusev E, Topchyan A. Cardiac arrhythmias and sudden unexpected death in epilepsy: Results of long-term monitoring. Heart Rhythm. 2021 Feb;18(2):221-228. doi: 10.1016/j.hrthm.2020.09.002. Epub 2020 Sep 8.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 16, 2015
• Primary Completion (ACTUAL): December 15, 2019
• Study Completion (ACTUAL): December 15, 2019

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: December 15, 2017
• First Posted (ACTUAL): December 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 7, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Epilepsy; sudden cardiac death; loop recorder; heart block
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Arrhythmias, Cardiac
• Other Study ID Numbers: 09-04/15 - 6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No