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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02001480

Enrollment

Registered

2013-12-05

Start date

2013-10-31

Completion date

2015-12-31

Last updated

2016-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2, End Stage Renal Disease

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.

Interventions

DEVICE12 lead Holter

12 lead Holter measurements will be performed for 7 days

DEVICECGM Continuous Glucose Monitoring

CGM will be performed continously for 7 days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026