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

Cardiovascular Diseases Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04876963
• Other study ID #: HOLT-ED protocol 1.10
• Status: Active, not recruiting
• Start date: September 1, 2021
• Est. completion date: September 5, 2024

Study information

• Verified date: February 2024
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 268
• Est. completion date: September 5, 2024
• Est. primary completion date: September 5, 2024
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Holter-monitor
7-day holtermonitoring of each patient

Locations

Country	Name	City	State
Denmark	Dept. of Nephrology, Rigshospitalet	Copenhagen
Denmark	Herlev Hospital	Herlev
Denmark	North Zealand Hospital	Hillerød

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical hypoglycemia	Clinical hypoglycemia in connection with holtermonitoring at baseline	Baseline
Other	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
Primary	Sudden cardiac death / lethal arrhythmia	Risk of sudden cardiac death or lethal arrhythmia within one year	1-year follow up
Primary	Cardiovascular death	Risk of cardiovascular death within one year	1-year follow up
Primary	All-cause mortality	Risk of all-cause mortality within one year	1-year follow up
Primary	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