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

NCT ID: NCT02001480

Last Updated: 2016-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-12-31

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.

Conditions

Diabetes Mellitus Type 2; End Stage Renal Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Echocardiography

12 lead holter for 7 days

CGM = continuous Glucose Monitoring

Group Type: OTHER

12 lead Holter

Intervention Type: DEVICE

12 lead Holter measurements will be performed for 7 days

CGM Continuous Glucose Monitoring

Intervention Type: DEVICE

CGM will be performed continously for 7 days

Interventions

12 lead Holter

12 lead Holter measurements will be performed for 7 days

Intervention Type: DEVICE

CGM Continuous Glucose Monitoring

CGM will be performed continously for 7 days

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nikolaus Marx, Univ.-Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine University Hospital Aachen

Locations

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

Countries

Germany

Other Identifiers

12-039

Identifier Type: -

Identifier Source: org_study_id