- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04036695
Arrhythmia in Hemodialysis Patients
Investigation of Electrophysiological Substrate of Arrhythmia in Hemodialysis Patients
Study Overview
Status
Conditions
Intervention / 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jarrin Penny, RN
- Phone Number: 58765 519 685-8500
- Email: Jarrin.Penny@lhsc.on.ca
Study Contact Backup
- Name: Lisa Hur
- Email: lhur@uwo.ca
Study Locations
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-
Ontario
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London, Ontario, Canada, N6A 5A5
- University Hospital
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London, Ontario, Canada, N6K 1M6
- Kidney Care Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Reveal LINQ insertable cardiac monitoring system
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Temporal association between dialysis induced cardiac injury and frequency of arrhythmia
Time Frame: Through heart monitoring of 12 months
|
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.
Time Frame: Through imaging session, on average of 4 hours
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christopher W McIntyre, MD, London Health Sciences Centre
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 113905
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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