Surrogate Markers for Sudden Cardiac Death in Patients With Diabetes Mellitus and End Stage Renal Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- RWTH Aachen University
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- ECG surrogate markers compared to cardiac events
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with diabetes mellitus type 2
- •chronic hemodialysis at least since 3 months
- •aged above 18 years
- •written informed consent
- •legally competent
Exclusion Criteria
- •intake of bets-blockker within the last four weeks
- •pregnancy and breast feeding
- •abuse of drugs and alcohol
- •missing compliance
- •life expectancy < 6 month
Arms & Interventions
Echocardiography
12 lead holter for 7 days
CGM = continuous Glucose Monitoring
Intervention: 12 lead Holter (Device)
Echocardiography
12 lead holter for 7 days
CGM = continuous Glucose Monitoring
Intervention: CGM Continuous Glucose Monitoring (Device)
Outcomes
Primary Outcomes
ECG surrogate markers compared to cardiac events
Time Frame: 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)
Secondary Outcomes
- Continuous glucose monitoring is performed to identify episodes of hypoglycaemia(Analysis will be done after last patient is out)