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

RWTH Aachen University

Status: Completed

Conditions: Diabetes Mellitus Type 2; End Stage Renal Disease

Treatments: Device: 12 lead Holter; Device: CGM Continuous Glucose Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT02001480

12-039

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Echocardiography

Other group

Description:

12 lead holter for 7 days CGM = continuous Glucose Monitoring

Treatment:

Device: CGM Continuous Glucose Monitoring

Device: 12 lead Holter