Cardiac Monitoring System for Arrhythmia in Hemodialysis Patients

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byChristopher W McIntyre, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Lawson Health Research Institute

No Placebo Group

Trial Summary

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.

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

I am 18 years old or older.

Able/willing to provide informed consent

I have been on hemodialysis for at least 3 months.

+1 more

Exclusion Criteria

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

I have a pacemaker or an implantable cardioverter defibrillator.

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Reveal LINQ insertable cardiac monitoring systemExperimental Treatment1 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.