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

January 19, 2016 updated by: RWTH Aachen University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bayern
      • Coburg, Bayern, Germany, 96450
        • REGIOMED-KLINIKEN GmbH
      • Würzburg, Bayern, Germany, 97080
        • University Hospital Wurzburg
    • NRW
      • Aachen, NRW, Germany, 52074
        • Department of Internal Medicine I University Hospital RWTH Aachen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Echocardiography

12 lead holter for 7 days

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ECG surrogate markers compared to cardiac events
Time Frame: 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)
Analysis will be performed after last patient is out

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continuous glucose monitoring is performed to identify episodes of hypoglycaemia
Time Frame: 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)
Analysis will be done after last patient is out

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Investigators

  • Principal Investigator: Nikolaus Marx, Univ.-Prof., Department of Internal Medicine University Hospital Aachen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

October 23, 2013

First Submitted That Met QC Criteria

November 27, 2013

First Posted (Estimate)

December 5, 2013

Study Record Updates

Last Update Posted (Estimate)

January 20, 2016

Last Update Submitted That Met QC Criteria

January 19, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-039

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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