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 Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
60
12 lead Holter measurements will be performed for 7 days
CGM will be performed continously for 7 days
regioMed-Kliniken GmbH
Coburg, Bavaria, Germany
University Hospital Würzburg
Würzburg, Bavaria, Germany
Department of Internal Medicine I University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, Germany
ECG surrogate markers compared to cardiac events
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)
Time frame: Analysis will be performed after last patient is out
Continuous glucose monitoring is performed to identify episodes of hypoglycaemia
Recruiting/active Period: October 2013 - April 2014 (6 months)/ Last patient out: April 2014/ Data cleaning, processing, analysis, study report: May 2014 - October 2014 (6 months)
Time frame: Analysis will be done after last patient is out
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