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

Active, not recruiting

• Conditions: Renal Insufficiency; Heart Diseases; Kidney Failure, Chronic; Arrhythmias, Cardiac; Kidney Diseases; Renal Insufficiency, Chronic; Cardiovascular Diseases

• Registration Number: NCT04876963
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

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 Timeline

• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-03
• Study First Posted: 2021-05-07
• Study Start: 2021-09-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26
• Primary Completion: 2024-09-05
• Study Completion: 2024-09-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 268

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (3)

Dept. of Nephrology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark

North Zealand Hospital; 🇩🇰 Hillerød, Denmark

Herlev Hospital; 🇩🇰 Herlev, Denmark