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临床试验/NCT02001480
NCT02001480已完成不适用

Surrogate Markers for Sudden Cardiac Death in Patients With Diabetes Mellitus and End Stage Renal Disease

RWTH Aachen University3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年10月1日最近更新:
适应症
干预措施

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

Other

12 lead holter for 7 days

CGM = continuous Glucose Monitoring

干预措施: 12 lead Holter (Device)

Echocardiography

Other

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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