Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006372

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00006372
  •   2015/04/09
  •   2013/10/23
  •   yes
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Secondary IDs

  •   NCT02001480  (ClinicalTrials.gov)
  •   12-039  (RWTH Aachen University)
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Health Condition or Problem studied

  •   Diabetes Mellitus Type 2
  •   End Stage Renal Disease
  •   E11 -  Non-insulin-dependent diabetes mellitus
  •   N18.5 -  Chronic kidney disease, stage 5
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Interventions/Observational Groups

  •   Device: 12 lead Holter
  •   Device: CGM Continuous Glucose Monitoring
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
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Primary Outcome

- 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)

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Secondary Outcome

- 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)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2013/10/31
  •   60
  •   Multicenter trial
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- patients with diabetes mellitus type 2

- chronic hemodialysis at least since 3 months

- aged above 18 years

- written informed consent

- legally competent

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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

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Addresses

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    • RWTH Aachen University
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    • Department of Internal Medicine University Hospital Aachen
    • Nikolaus Marx, Univ.-Prof. 
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    • Nikolaus Marx, Univ.-Prof. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/07/16
* This entry means the parameter is not applicable or has not been set.