HOLT-ED: Holter-monitoring in End-stage Renal Disease

Last updated: February 23, 2024
Sponsor: Rigshospitalet, Denmark
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Nephropathy

Circulation Disorders

Renal Failure

Treatment

Holter-monitor

Clinical Study ID

NCT04876963
HOLT-ED protocol 1.10
  • Ages > 18
  • All Genders

Study Summary

The main objective of this prospective cohort study is to assess arrhythmia burden and glycemic variability in a multicenter cohort of patients with end-stage renal disease using a sufficient observation period in order to identify arrhythmia burden and type and characterize associations with patient characteristics and dialysis treatment, glycemic variability and subsequent risk of adverse outcomes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Dialysis-treated end-stage renal disease
  • Age ≥ 18 years
  • Competence to understand the study rationale necessary for written informed consent

Exclusion

Exclusion Criteria:

  • Pre-existing pacemaker implantation

Study Design

Total Participants: 268
Treatment Group(s): 1
Primary Treatment: Holter-monitor
Phase:
Study Start date:
September 01, 2021
Estimated Completion Date:
September 05, 2024

Study Description

Background: The risk of dying of a cardiovascular disease is 10-20 times increased in patients dependent on dialysis treatment compared to the general population. 1/3 of these deaths is caused by arrhythmia and 'sudden cardiac death'.

Purpose: Investigate the prevalence and type of arrhythmia in patients dependent on dialysis treatment, including the association with patient- and dialysis related factors and cardiovascular outcomes.

Methods: 7-days Holter-monitoring with Cortrium C3+ holter-monitor in 540 patients dependent on dialysis treatment in the Capital Region of Denmark. Continous blood glucose monitoring in a subgroup. 1-year follow-up via national registers.

Endpoints:

  • Prevalence of atrial fibrillation

  • Prevalence of other arrhythmia (tachycardia, bradycardia, AV-block)

  • Follow-up outcomes: sudden cardiac death, cardiovascular disease and cardiovascular death

Connect with a study center

  • Dept. of Nephrology, Rigshospitalet

    Copenhagen, 2100
    Denmark

    Site Not Available

  • Herlev Hospital

    Herlev,
    Denmark

    Site Not Available

  • North Zealand Hospital

    Hillerød,
    Denmark

    Site Not Available

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