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

Study Overview
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Brief Summary
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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.

Conditions
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Diabetes Mellitus Type 2, End Stage Renal Disease

Intervention / Treatment
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* Device: 12 lead Holter
* Device: CGM Continuous Glucose Monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Echocardiography<br>12 lead holter for 7 days CGM = continuous Glucose Monitoring | Device: 12 lead Holter<br>* 12 lead Holter measurements will be performed for 7 days<br>Device: CGM Continuous Glucose Monitoring<br>* CGM will be performed continously for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Analysis will be performed after last patient is out | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Analysis will be done after last patient is out |