Clinical trial NCT04876963: HOLT-ED: Holter-monitoring in End-stage Renal Disease
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Kidney Failure, Chronic
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with dialysis-treated end-stage renal disease over the age of 18 and without pacemaker implantation.

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

Eligibility criteria: 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

Primary outcomes:
measure: Sudden cardiac death / lethal arrhythmia
timeFrame: 1-year follow up
measure: Cardiovascular death
timeFrame: 1-year follow up
measure: All-cause mortality
timeFrame: 1-year follow up
measure: Myocardial infarction or death attributable to myocardial infarction
timeFrame: 1-year follow up
Secondary outcomes:
Other outcomes:
measure: Clinical hypoglycemia
timeFrame: Baseline
measure: De novo cardiac arrhythmia (atrial fibrillation or flutter, advanced second-degree or third degree
timeFrame: Baseline
Locations:
city: Copenhagen
country: Denmark
facility: Dept. of Nephrology, Rigshospitalet
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Hillerød
country: Denmark
facility: North Zealand Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Nicholas Carlson, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: