Trials / Unknown
UnknownNCT04876963
HOLT-ED: Holter-monitoring in End-stage Renal Disease
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
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 268 (actual)
- Sponsor
- Rigshospitalet, Denmark · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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
Conditions
- Kidney Failure, Chronic
- Arrhythmias, Cardiac
- Heart Diseases
- Cardiovascular Diseases
- Kidney Diseases
- Renal Insufficiency, Chronic
- Renal Insufficiency
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Holter-monitor | 7-day holtermonitoring of each patient |
Timeline
- Start date
- 2021-09-01
- Primary completion
- 2024-09-05
- Completion
- 2024-09-05
- First posted
- 2021-05-07
- Last updated
- 2024-02-26
Locations
3 sites across 1 country: Denmark
Source: ClinicalTrials.gov record NCT04876963. Inclusion in this directory is not an endorsement.