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

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

Non Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

  • Pre-existing pacemaker implantation

Study details
    Kidney Failure
    Chronic
    Arrhythmias
    Cardiac
    Heart Diseases
    Cardiovascular Diseases
    Kidney Diseases
    Renal Insufficiency
    Chronic
    Renal Insufficiency

NCT04876963

Rigshospitalet, Denmark

20 August 2025

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