Arrhythmia in Hemodialysis Patients

NCT04036695 | Active Not Recruiting

• 1 other identifier: 113905
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

Patients receiving dialysis for kidney failure suffer from very high rates of sudden cardiac death due to abnormal heart rhythms and perfusion defects associated with HD treatment. It has previously been recognized that patients suffer heart injury during the dialysis procedure which may be an important factor for investigation. The study uses a simple implantable device that can monitor heart rhythms over time to gather information on the type of abnormal rhythms that occur in dialysis patients. This information will be combined with ultrasound and x-ray scans of the heart that will also be collected. The goal is to understand the relationship between the abnormal rhythms and injury to the heart during dialysis and what causes these injuries. The information gathered in this study will be used to compare the accuracy of an in house personalized computational model to predict potential cardiac injuries when patients undergo HD treatment.

Conditions

Arrythmia, Cardiac; Sudden Cardiac Death; Hemodialysis

Outcome Measures

Primary Outcomes (2)

• Temporal association between dialysis induced cardiac injury and frequency of arrhythmia

  The primary outcome will be to determine the correlation between dialysis cardiac injury and the rate of arrhythmia. This will be measured by comparing perfusion heterogeneity in CT images to the rhythms recorded on the Reveal LINQ heart monitor.

  Through heart monitoring of 12 months

• Temporal association between dialysis induced cardiac injury and electrophysiological substrate responsible for arrhythmia.

  The primary outcome will be to determine the correlation between dialysis cardiac injury and the electrophysiological substrate responsible for arrhythmia. This will be measured by comparing perfusion heterogeneity in CT images to the results of the electrophysiological maps.

  Through imaging session, on average of 4 hours

Study Arms (1)

Reveal LINQ insertable cardiac monitoring system

EXPERIMENTAL

In this all study, participants will have the option to undergo an insertion procedure of the Reveal LINQ insertable cardiac monitoring system on a dialysis or non-dialysis treatment day at University Hospital. The implantable loop recorder will be monitored at least once a week for up to 12 months.

Device: Reveal LINQ insertable cardiac monitoring system

Interventions

Reveal LINQ insertable cardiac monitoring system DEVICE

A small implantable cardiac monitor (Reveal LINQ device) will be inserted under local anaesthetic in an outpatient procedure. The Reveal LINQ device is composed of two electrodes and is used to continuously monitor electric activity temporally. It can detect arrhythmic episode and record up to 27 minutes of electrocardiographic (ECG) activity. This device is capable of continuous monitoring of patient's ECG activity for up to three years and will be utilized in this study to obtain initial information on the timing and nature of the arrhythmia suffered by hemodialysis patients leading to SCD.

Reveal LINQ insertable cardiac monitoring system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No significant residual renal function (\<250ml of urine per day).
• Must be on hemodialysis for at least 3 months
• Age ≥18 years
• Able/willing to provide informed consent

You may not qualify if:

• Presence of a pacemaker and implantable cardioverter defibrillator
• Prior diagnosis of chronic arrhythmia and/or are on anti-arrhythmic drugs

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (2)

University Hospital

London, Ontario, N6A 5A5, Canada

Location

Kidney Care Centre

London, Ontario, N6K 1M6, Canada

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Death, Sudden; Death

Study Officials

• Christopher W McIntyre, MD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Medical Biophysics, and Paediatrics

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 30, 2019
• Study Start: October 17, 2019
• Primary Completion: May 1, 2023
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)