Time-Domain Heart Rate Variability and QT Interval in Children With Epilepsy

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorAssiut University

About this trial

Epilepsy is a chronic neurological disorder characterized by recurrent unprovoked seizures, but it can also affect the autonomic nervous system and cardiovascular function. Certain anti-epileptic medications and seizure activity may influence cardiac rhythm, beat-to-beat heart rate variability (HRV), and ventricular repolarization (measured by the QT interval). The primary purpose of this study is to evaluate autonomic tone and cardiac electrical conduction in children with epilepsy receiving anti-epileptic drugs by measuring time-domain HRV and the corrected QT (QTc) interval, comparing patients on monotherapy, patients on polytherapy, and healthy controls.

A total of 60 children aged 1 to 18 years will be enrolled across three groups: 20 children with epilepsy receiving single-drug therapy (monotherapy), 20 children with epilepsy receiving two or more medications (polytherapy), and 20 healthy children serving as controls.

All participants will complete non-invasive assessments during a single visit, including:

* Collection of clinical and demographic data (age, sex, epilepsy duration, and medication details) * A standard 12-lead electrocardiogram (ECG) to measure the QT interval and calculate the QTc using Fridericia's formula * A 5-minute continuous resting ECG recorded in a supine position after 10 minutes of quiet rest to calculate time-domain HRV parameters (SDNN, RMSSD, and pNN50)

The findings aim to detect early autonomic or electrophysiological alterations, aiding in the understanding of cardiac safety in pediatric epilepsy management.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 1 and 18 years

Confirmed diagnosis of epilepsy according to International League Against Epilepsy (ILAE) criteria (for epileptic cohorts)

Receiving anti-epileptic medication for 3 months or more (for epileptic cohorts)

Healthy children matched by age and sex (for control cohort)

Disqualifiers

Age younger than 1 year or older than 18 years

Structural heart disease

Chronic systemic illness

Acute illness at the time of study evaluation

Trial population

Eligible children aged 1 to 18 years presenting to the Pediatric Neurology Department at Assiut University Children's Hospital, Assiut, Egypt. The population comprises pediatric patients with a confirmed diagnosis of epilepsy according to ILAE criteria maintained on anti-epileptic monotherapy or polytherapy for at least 3 months, alongside age- and sex-matched healthy controls.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 3 trial groups
Group A: Group I: Monotherapy
Group B: Group II: Polytherapy
Group C: Group III: Healthy Controls

Trial outcomes

Primary outcomes

1

Corrected QT Interval (QTc)

Corrected QT interval (reported in milliseconds) measured from a standard 12-lead ECG recorded at standard velocity and amplitude. The QT interval is measured in lead V5 (or lead II if lead V5 is unsuitable) across three consecutive cardiac cycles and averaged. QTc is calculated using Fridericia's formula: QTc = QT / RR\^(1/3).

Time frame
Baseline

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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