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Arrhythmia in Hemodialysis Patients

Primary Purpose

Arrythmia, Cardiac, Sudden Cardiac Death, Hemodialysis

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Reveal LINQ insertable cardiac monitoring system
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Arrythmia, Cardiac

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • University HospitalRecruiting
  • Kidney Care CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Reveal LINQ insertable cardiac monitoring system

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 17, 2019
Last Updated
December 21, 2022
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04036695
Brief Title
Arrhythmia in Hemodialysis Patients
Official Title
Investigation of Electrophysiological Substrate of Arrhythmia in Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2019 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
This is an exploratory, single group, observational study involving patients recruited from the dialysis patient population of the London Health Science Centre (LHSC) Regional Renal Program. Recruited patients will undergo insertion of the Reveal LINQ insertable cardiac monitoring system and will continuously be examined over a time period of up to 12 to 24 months to gather data on the incidence of arrhythmia. Those patients enrolled into the study will have their first study session on their midweek dialysis treatment day (Wednesday or Thursday) at St. Joseph's Hospital. During the first study visit, all participants will have an external multichannel ECG, CT scan, CT angiogram, and 2D echo done. In addition to this, all participants will have non-invasive monitoring of circulatory stress using the CVInsight contact device, and blood work will be drawn. Within one month, all participants will have a second study visit where they will undergo the same study procedures as in session one with the addition of up to 30 minutes of intradialytic exercise. This visit will also take place at St. Joseph's Hospital on a mid-week dialysis treatment day. If a patient would like to, they will then undergo an insertion procedure of the Reveal LINQ insertable cardiac monitoring system on a dialysis or non-dialysis treatment day at University Hospital. Dr. Allan Skanes (CoInvestigator) will perform this procedure at his earliest convenience. The implantable loop recorder will be interrogated at least once a month for up to 12 months to retrieve the information that has been recorded during their hemodialysis treatment. During this time, the patient participant will complete a questionnaire too using the LEVIL application. Then, 12 months after the initial insertion of the device, a follow-up call will be completed by a member of the research team where the patient will have the choice to have the device removed if desired. If the patient chooses to keep the device, we will monitor the implantable loop recorder for another year and the patient will be transferred to LHSC's Inherited Heart Rhythm Clinic at University Hospital for clinical monitoring after this. Completion of the questionnaire will continue during this time. If they choose to have the device removed, the cardiac electrophysiologist will remove the device at his earliest convenience. Bloodwork will be obtained pre and post dialysis as well as at peak stress of each imaging session. This will allow us to assess for relevant biomarkers of oxidative stress, myocardial ischemia, and volume overload.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrythmia, Cardiac, Sudden Cardiac Death, Hemodialysis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reveal LINQ insertable cardiac monitoring system
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Reveal LINQ insertable cardiac monitoring system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Temporal association between dialysis induced cardiac injury and frequency of arrhythmia
Description
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.
Time Frame
Through heart monitoring of 12 months
Title
Temporal association between dialysis induced cardiac injury and electrophysiological substrate responsible for arrhythmia.
Description
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.
Time Frame
Through imaging session, on average of 4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Presence of a pacemaker and implantable cardioverter defibrillator Prior diagnosis of chronic arrhythmia and/or are on anti-arrhythmic drugs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jarrin Penny, RN
Phone
519 685-8500
Ext
58765
Email
Jarrin.Penny@lhsc.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Hur
Email
lhur@uwo.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher W McIntyre, MD
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jarrin Penny, RN
Phone
519.685.8500
Ext
58765
Email
Jarrin.Penny@lhsc.on.ca
Facility Name
Kidney Care Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6K 1M6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jarrin Penny, RN
Phone
519.685.8500
Ext
58765
Email
Jarrin.Penny@lhsc.on.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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Arrhythmia in Hemodialysis Patients

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