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NCT Number: NCT04876963

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

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.

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Key information

Conditions

Kidney Failure, Chronic Arrhythmias, Cardiac Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. of Nephrology, Rigshospitalet, Copenhagen, Denmark

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About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Holter-monitor

Device

7-day holtermonitoring of each patient

Primary outcomes

  1. Sudden cardiac death / lethal arrhythmia

    Time frame: 1-year follow up

    Risk of sudden cardiac death or lethal arrhythmia within one year

  2. Cardiovascular death

    Time frame: 1-year follow up

    Risk of cardiovascular death within one year

  3. All-cause mortality

    Time frame: 1-year follow up

    Risk of all-cause mortality within one year

  4. Myocardial infarction or death attributable to myocardial infarction

    Time frame: 1-year follow up

    Risk of Myocardial infarction or death attributable to myocardial infarction within one year

Other outcomes

  1. Clinical hypoglycemia

    Time frame: Baseline

    Clinical hypoglycemia in connection with holtermonitoring at baseline

  2. De novo cardiac arrhythmia (atrial fibrillation or flutter, advanced second-degree or third degree

    Time frame: Baseline

    De novo cardiac arrhythmia (atrial fibrillation or flutter, advanced second-degree or third degree at baseline

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

HOLT-ED: Holter-monitoring in End-stage Renal Disease - Does Burden of Arrhythmia Assessed With Systematic Holter Electrocardiogram Monitoring Affect Cardiovascular Outcomes? - A Prospective Cohort Study

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
May 7, 2021
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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