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

Not Applicable

Completed

• Conditions: Diabetes Mellitus Type 2; End Stage Renal Disease
• Interventions: Device: 12 lead Holter; Device: CGM Continuous Glucose Monitoring

• Registration Number: NCT02001480
• Lead Sponsor: RWTH Aachen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-23
• Study First Submitted QC: 2013-11-27
• Study First Posted: 2013-12-05
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-19
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Echocardiography	12 lead Holter	12 lead holter for 7 days CGM = continuous Glucose Monitoring
Echocardiography	CGM Continuous Glucose Monitoring	12 lead holter for 7 days CGM = continuous Glucose Monitoring

Primary Outcome Measures

Name	Time	Method
ECG surrogate markers compared to cardiac events	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 Outcome Measures

Name	Time	Method
Continuous glucose monitoring is performed to identify episodes of hypoglycaemia	Analysis will be done after last patient is out	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)

Trial Locations

Locations (3)

regioMed-Kliniken GmbH; 🇩🇪 Coburg, Bayern, Germany

Department of Internal Medicine I University Hospital RWTH Aachen; 🇩🇪 Aachen, NRW, Germany

University Hospital Würzburg; 🇩🇪 Würzburg, Bayern, Germany