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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04876963
Other study ID # HOLT-ED protocol 1.10
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
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