Cardiac Monitoring System for Arrhythmia in Hemodialysis Patients

Recruiting at 1 trial location

Overseen By Lisa Hur

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lawson Health Research Institute

Must not be taking: Anti-arrhythmic drugs

Disqualifiers: Pacemaker, Chronic arrhythmia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

18 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on anti-arrhythmic drugs, you cannot participate in the study.

What data supports the effectiveness of the treatment Reveal LINQ insertable cardiac monitoring system for arrhythmia in hemodialysis patients?

The research highlights that arrhythmia-related complications are common in dialysis patients, and implantable cardiac monitors like Reveal LINQ offer a new way to detect and manage these issues. Patients and family members recognize the high risk of heart problems in dialysis, and the continuous monitoring provided by these devices can help address this concern. ^{1 2 3 4 5}

Is the Reveal LINQ insertable cardiac monitoring system safe for use in humans?

The available research does not provide specific safety data for the Reveal LINQ system, but implantable cardiac monitors are generally used in clinical settings to continuously monitor heart rhythms without needing wires inside the veins, suggesting they are considered safe for use in humans. ^{2 3 4 5 6}

How does the cardiac monitoring system for arrhythmia in hemodialysis patients differ from other treatments?

This treatment is unique because it involves continuous cardiac monitoring specifically designed for hemodialysis patients, who have fluctuating cardiovascular and electrolyte levels. Unlike traditional methods, this system can provide real-time data during dialysis sessions, potentially improving the detection and management of arrhythmias. ^{2 3 4 7 8}

What is the purpose of this trial?

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.

Research Team

Christopher W McIntyre, MD

Principal Investigator

London Health Sciences Centre

Eligibility Criteria

This trial is for adults over 18 who've been on hemodialysis for kidney failure for at least 3 months and produce less than 250ml of urine per day. They must be able to consent to the study. It's not open to those with pacemakers, defibrillators, a history of chronic arrhythmia, or those taking anti-arrhythmic drugs.

Inclusion Criteria

Able/willing to provide informed consent

I have been on hemodialysis for at least 3 months.

I produce less than 250ml of urine daily.

Exclusion Criteria

I have a long-term irregular heartbeat and/or take medication for it.

I have a pacemaker or an implantable cardioverter defibrillator.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Study Visits

Participants undergo external multichannel ECG, CT scan, CT angiogram, 2D echo, non-invasive monitoring of circulatory stress, and blood work during their midweek dialysis treatment day.

1 month

2 visits (in-person)

Device Insertion and Monitoring

Participants may undergo insertion of the Reveal LINQ insertable cardiac monitoring system, which will be monitored at least once a month for up to 12 months.

12 months

Monthly monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a follow-up call 12 months after device insertion. Participants can choose to have the device removed or continue monitoring.

12 months

Treatment Details

Interventions

• Reveal LINQ insertable cardiac monitoring system

Trial Overview The trial is testing an implantable heart rhythm monitor called Reveal LINQ in dialysis patients. The device will track heart rhythms to investigate the link between dialysis treatment and cardiac injuries that can lead to sudden death.

Participant Groups

Group I: Reveal LINQ insertable cardiac monitoring system Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

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

Lead Sponsor

Trials

668

Recruited

424,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

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

Lead Sponsor

Trials

678

Recruited

421,000+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Sudden cardiac death in hemodialysis patients: a comprehensive care approach to reduce risk. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Frequency of arrhythmia symptoms and acceptability of implantable cardiac monitors in Hemodialysis patients. [2018]

3. Italy pubmed.ncbi.nlm.nih.gov

[Clinical practice for the diagnosis of cardiac arrhythmias in patients on renal replacement therapy: data from a Lombard survey]. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

T wave morphology changes during hemodialysis. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Patients' and family members' perspectives on arrhythmias and sudden death in dialysis: the HeartLink focus groups pilot study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Association of QRS-T angle and heart rate variability with major cardiac events and mortality in hemodialysis patients. [2021]

7. Italy pubmed.ncbi.nlm.nih.gov

[Relationship between late ventricular potentials and ventricular arrhythmias in patients in chronic dialysis treatment]. [2007]

8. Germany pubmed.ncbi.nlm.nih.gov

Electrocardiographic substrates of arrhythmias in patients with end-stage and chronic kidney diseases: a case-control study. [2023]