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

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ClinicalTrials.gov Identifier: NCT02001480
Recruitment Status : Completed
First Posted : December 5, 2013
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 End Stage Renal Disease Device: 12 lead Holter Device: CGM Continuous Glucose Monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : October 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02001480


Locations
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Germany
regioMed-Kliniken GmbH
Coburg, Bayern, Germany, 96450
University Hospital Würzburg
Würzburg, Bayern, Germany, 97080
Department of Internal Medicine I University Hospital RWTH Aachen
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Principal Investigator: Nikolaus Marx, Univ.-Prof. Department of Internal Medicine University Hospital Aachen

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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT02001480     History of Changes
Other Study ID Numbers: 12-039
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency