HOLT-ED: Holter-monitoring in End-stage Renal Disease
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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
Enrollment
Sex
Ages
Volunteers
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
Trial contacts and locations
Loading...
Central trial contact
Ellen Linnea F Ballegaard, MD; Nicholas Carlson, MD PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal