Cardiovascular Diseases Clinical Trial
Official title:
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
Verified date | February 2024 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Dept. of Nephrology, Rigshospitalet | Copenhagen | |
Denmark | Herlev Hospital | Herlev | |
Denmark | North Zealand Hospital | Hillerød |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
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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