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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.
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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Holter-monitor | Device | 7-day holtermonitoring of each patient |
| Measure | Description | Time Frame |
|---|---|---|
| Sudden cardiac death / lethal arrhythmia | Risk of sudden cardiac death or lethal arrhythmia within one year | 1-year follow up |
| Cardiovascular death | Risk of cardiovascular death within one year | 1-year follow up |
| All-cause mortality | Risk of all-cause mortality within one year | 1-year follow up |
| 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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| Measure | Description | Time Frame |
|---|---|---|
| Clinical hypoglycemia | Clinical hypoglycemia in connection with holtermonitoring at baseline | Baseline |
| De novo cardiac arrhythmia (atrial fibrillation or flutter, advanced second-degree or third degree |
Inclusion Criteria:
Exclusion Criteria:
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Patients with dialysis-treated end-stage renal disease over the age of 18 and without pacemaker implantation.
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Carlson, MD PhD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Nephrology, Rigshospitalet | Copenhagen | Copenhagen | 2100 | Denmark | ||
| Herlev Hospital |
Tabulated study data and protocols will be made available (within limitations of Danish legislation related to GDPR)
within 1 year of study completion
Data access will be available upon approval via Statistics Denmark
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D007674 | Kidney Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D015716 | Electrocardiography, Ambulatory |
| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
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De novo cardiac arrhythmia (atrial fibrillation or flutter, advanced second-degree or third degree at baseline
| Baseline |
| Herlev |
| Denmark |
| North Zealand Hospital | Hillerød | Denmark |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |