Arrythmia, CardiacNCT04036695
Arrhythmia in Hemodialysis Patients
A study testing Reveal LINQ insertable cardiac monitoring system in people with Arrythmia, Cardiac and Sudden Cardiac Death, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrythmia, Cardiac, Sudden Cardiac Death, Hemodialysis
- What is being tested?
- Reveal LINQ insertable cardiac monitoring system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesCanada
- Study dates
- 17 Oct 2019to 24 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of a pacemaker and implantable cardioverter defibrillator
- Prior diagnosis of chronic arrhythmia and/or are on anti-arrhythmic drugs
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University Hospital
London, Ontario, N6A 5A5
Kidney Care Centre
London, Ontario, N6K 1M6
About this study
Official title: Investigation of Electrophysiological Substrate of Arrhythmia in Hemodialysis Patients
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.
Read the 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.
- Conditions
- Arrythmia, Cardiac, Sudden Cardiac Death, Hemodialysis
- Being tested
- Reveal LINQ insertable cardiac monitoring system
- Medical subject headings
- Arrhythmias, Cardiac, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reveal LINQ insertable cardiac monitoring systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Reveal LINQ insertable cardiac monitoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through imaging session, on average of 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start17 Oct 2019
- Primary completion1 May 2023
- Study completion24 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrythmia, CardiacStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chris McIntyre, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Christopher W McIntyre, MD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036695
- Sponsor's protocol ID
- 113905
- Status last verified
- Jun 2026
- First submitted
- 17 Jul 2019
- Last updated
- 26 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Electrophysiological Substrate of Arrhythmia in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT04036695
- Acronym / sponsor ID
- 113905
- Conditions
- Arrythmia, Cardiac, Sudden Cardiac Death, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 17 Oct 2019 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 24 Jun 2026 (actual)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reveal LINQ insertable cardiac monitoring system | Experimental | Device: Reveal LINQ insertable cardiac monitoring systemIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Presence of a pacemaker and implantable cardioverter defibrillator
- Prior diagnosis of chronic arrhythmia and/or are on anti-arrhythmic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reveal LINQ insertable cardiac monitoring systemA 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. | Device | Reveal LINQ insertable cardiac monitoring system |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher W McIntyre, MD principal investigator
London Health Sciences Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reveal LINQ insertable cardiac monitoring system in people with Arrythmia, Cardiac and Sudden Cardiac Death, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temporal association between dialysis induced cardiac injury and frequency of arrhythmia (time frame: Through heart monitoring of 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.