NCT02001480

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: RWTH Aachen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus Type 2
• End Stage Renal Disease

Interventions

Type	Name	Description
DEVICE	12 lead Holter	12 lead Holter measurements will be performed for 7 days
DEVICE	CGM Continuous Glucose Monitoring	CGM will be performed continously for 7 days

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-12-05
• Last updated: 2016-01-20

Locations

3 sites across 1 country: Germany