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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 268
- 试验地点
- 4
- 主要终点
- Sudden cardiac death / lethal arrhythmia
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dialysis-treated end-stage renal disease
- •Age ≥ 18 years
- •Competence to understand the study rationale necessary for written informed consent
排除标准
- •Pre-existing pacemaker implantation
结局指标
主要结局
Sudden cardiac death / lethal arrhythmia
时间窗: 1-year follow up
Risk of sudden cardiac death or lethal arrhythmia within one year
Myocardial infarction or death attributable to myocardial infarction
时间窗: 1-year follow up
Risk of Myocardial infarction or death attributable to myocardial infarction within one year
All-cause mortality
时间窗: 1-year follow up
Risk of all-cause mortality within one year
Cardiovascular death
时间窗: 1-year follow up
Risk of cardiovascular death within one year
次要结局
未报告次要终点
研究者
Nicholas Carlson
MD PhD
Rigshospitalet, Denmark