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Cardiac Arrhythmia in Patients with End-Stage Renal Disease

NCT04841304 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2024-11-18

No results posted yet for this study

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

Interventions

DEVICE

Loop recorder (Reveal LINQ, Medtronic)

Implantation of a loop-recorder

DEVICE

Continuous Glucose Measurement (G6, Dexcom)

Monitoring with a continuous glucose monitor

Sponsors & Collaborators

  • Herlev Hospital

    collaborator OTHER

  • Steno Diabetes Center Copenhagen

    collaborator OTHER

  • University of Copenhagen

    collaborator OTHER

  • Hillerod Hospital, Denmark

    collaborator OTHER

  • Holbaek Sygehus

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2024-04-01
Completion
2026-04-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04841304 on ClinicalTrials.gov