Arrhythmias, Cardiac, Cardiovascular Diseases, Heart Diseases, Kidney Diseases, Kidney Failure, Chronic, Renal Insufficiency, Renal Insufficiency, Chronic
Conditions
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
Interventions
DEVICEHolter-monitor
7-day holtermonitoring of each patient
Sponsors
Rigshospitalet, Denmark
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sudden cardiac death / lethal arrhythmia | 1-year follow up | Risk of sudden cardiac death or lethal arrhythmia within one year |
| Cardiovascular death | 1-year follow up | Risk of cardiovascular death within one year |
| All-cause mortality | 1-year follow up | Risk of all-cause mortality 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 |
Countries
Denmark
Contacts
PRINCIPAL_INVESTIGATORNicholas Carlson, MD PhD
Rigshospitalet, Denmark
Outcome results
None listed