NCT04841304

Cardiac Arrhythmia in Patients with End-Stage Renal Disease

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will examine the presence of cardiac arrhythmias in patients receiving hemodialysis and the role of diabetes, hypoglycemia and parameters related to uremia and the dialysis procedure. The study is designed as a prospective cohort study with 18 months follow-up. 70 patients receiving chronic hemodialysis will be recruited and equipped with implantable loop recorders (ILR): 35 patients with diabetes and 35 patients without diabetes. Data collection during the follow-up includes continuous monitoring of the heart rhythm by the ILR for the entire follow-up period, continuous glucose monitoring for 10 days every second month, and monthly collection of blood samples and dialytic parameters. After the initial 18-month follow-up, heart rhythm monitoring will continue until the ILR battery runs out for those participants who wish to continue.

Conditions

• End Stage Renal Disease on Dialysis
• Cardiac Arrhythmia
• Diabetes Mellitus
• Hypoglycemia

Interventions

Type	Name	Description
DEVICE	Loop recorder (Reveal LINQ, Medtronic)	Implantation of a loop-recorder
DEVICE	Continuous Glucose Measurement (G6, Dexcom)	Monitoring with a continuous glucose monitor

Timeline

• Start date: 2021-06-01
• Primary completion: 2024-04-01
• Completion: 2026-04-01
• First posted: 2021-04-12
• Last updated: 2024-11-18

Locations

4 sites across 1 country: Denmark