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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Arrhythmias, Cardiac; Kidney Failure, Chronic
• Intervention / Treatment: Device: Holter-monitor

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 268

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark
    • Herlev Hospital
  • Hillerød, Denmark
    • North Zealand Hospital
  • Copenhagen
    • Copenhagen, Copenhagen, Denmark, 2100
      • Dept. of Nephrology, Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with dialysis-treated end-stage renal disease over the age of 18 and without pacemaker implantation.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sudden cardiac death / lethal arrhythmia	Risk of sudden cardiac death or lethal arrhythmia within one year	1-year follow up
Cardiovascular death	Risk of cardiovascular death within one year	1-year follow up
All-cause mortality	Risk of all-cause mortality within one year	1-year follow up
Myocardial infarction or death attributable to myocardial infarction	Risk of Myocardial infarction or death attributable to myocardial infarction within one year	1-year follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical hypoglycemia	Clinical hypoglycemia in connection with holtermonitoring at baseline	Baseline
De novo cardiac arrhythmia (atrial fibrillation or flutter, advanced second-degree or third degree	De novo cardiac arrhythmia (atrial fibrillation or flutter, advanced second-degree or third degree at baseline	Baseline

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Nicholas Carlson, MD PhD, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 17, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases; Heart Diseases; Renal Insufficiency; Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Arrhythmias, Cardiac; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Electrodiagnosis; Monitoring, Physiologic; Electrocardiography; Monitoring, Ambulatory; Electrocardiography, Ambulatory
• Other Study ID Numbers: HOLT-ED protocol 1.10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Tabulated study data and protocols will be made available (within limitations of Danish legislation related to GDPR)
• IPD Sharing Time Frame: within 1 year of study completion
• IPD Sharing Access Criteria: Data access will be available upon approval via Statistics Denmark
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No