Surrogate Markers for Sudden Cardiac Death in Patients With Diabetes Mellitus and End Stage Renal Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- ECG surrogate markers compared to cardiac events
研究概览
简要总结
Aim: Patients with type 2 diabetes mellitus (T2DM) and hemodialysis due to diabetic nephropathy exhibit a high risk for sudden cardiac death (SCD). Preliminary data suggest that beta-blocker treatment may reduce arrhythmias and mortality in this high-risk population. However, no results from large-scale clinical outcome trials with beta-blockers exist in this patient group and a broad, scientifically unapproved use of beta-blocker treatment may not be justified due to potential harmful side-effects such as AV-block or hypotension. In addition, we are lacking identified ECG surrogate parameters for SCD in this high-risk population and on the occurrence of arrhythmias in temporary relationship to hemodialysis sessions.
Therefore, the present study will identify surrogate parameters of SCD in hemodialysis patients with T2DM and in an interventional trial investigate the suppressive effect of beta-blockers on these identified ECG markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •patients with diabetes mellitus type 2
- •chronic hemodialysis at least since 3 months
- •aged above 18 years
- •written informed consent
- •legally competent
排除标准
- •intake of bets-blockker within the last four weeks
- •pregnancy and breast feeding
- •abuse of drugs and alcohol
- •missing compliance
- •life expectancy < 6 month
研究组 & 干预措施
Echocardiography
12 lead holter for 7 days
CGM = continuous Glucose Monitoring
干预措施: 12 lead Holter (Device)
Echocardiography
12 lead holter for 7 days
CGM = continuous Glucose Monitoring
干预措施: CGM Continuous Glucose Monitoring (Device)
结局指标
主要结局
ECG surrogate markers compared to cardiac events
时间窗: Analysis will be performed after last patient is out
Recruiting Period: October 2013 - April 2014 (6 months)/ Last patient out: April 2014/ Data cleaning, processing, analysis, study report: May 2014 - October 2014 (6 months)
次要结局
- Continuous glucose monitoring is performed to identify episodes of hypoglycaemia(Analysis will be done after last patient is out)
