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ACTIVE NOT RECRUITING
NCT04841304

Cardiac Arrhythmia in Patients with End-Stage Renal Disease

Sponsor: Rigshospitalet, Denmark

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

70

Start Date

2021-06-01

Completion Date

2026-04

Last Updated

2024-11-18

Healthy Volunteers

No

Interventions

DEVICE

Loop recorder (Reveal LINQ, Medtronic)

Implantation of a loop-recorder

DEVICE

Continuous Glucose Measurement (G6, Dexcom)

Monitoring with a continuous glucose monitor

Locations (4)

Department of Nephrology, Rigshospitalet

Copenhagen, Denmark

Department of Nephrology, Herlev Hospital

Herlev, Denmark

Department of Nephrology, North Zealand Hospital

Hillerød, Denmark

Department of Nephrology, Holbæk Sygehus

Holbæk, Denmark