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

End Stage Renal Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02001480
• Other study ID #: 12-039
• Status: Completed
• Phase: N/A
• First received: October 23, 2013
• Last updated: January 19, 2016
• Start date: October 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Device:
• 12 lead Holter
12 lead Holter measurements will be performed for 7 days
• CGM Continuous Glucose Monitoring
CGM will be performed continously for 7 days

Locations

Country	Name	City	State
Germany	Department of Internal Medicine I University Hospital RWTH Aachen	Aachen	NRW
Germany	regioMed-Kliniken GmbH	Coburg	Bayern
Germany	University Hospital Würzburg	Würzburg	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No