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

Primary Purpose

Diabetes Mellitus Type 2, End Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
12 lead Holter
CGM Continuous Glucose Monitoring
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • regioMed-Kliniken GmbH
  • University Hospital Würzburg
  • Department of Internal Medicine I University Hospital RWTH Aachen

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Echocardiography

Arm Description

12 lead holter for 7 days CGM = continuous Glucose Monitoring

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

Full Information

First Posted
October 23, 2013
Last Updated
January 19, 2016
Sponsor
RWTH Aachen University
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1. Study Identification

Unique Protocol Identification Number
NCT02001480
Brief Title
Surrogate Markers for Sudden Cardiac Death in Patients With Diabetes Mellitus and End Stage Renal Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2, End Stage Renal Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Echocardiography
Arm Type
Other
Arm Description
12 lead holter for 7 days CGM = continuous Glucose Monitoring
Intervention Type
Device
Intervention Name(s)
12 lead Holter
Intervention Description
12 lead Holter measurements will be performed for 7 days
Intervention Type
Device
Intervention Name(s)
CGM Continuous Glucose Monitoring
Intervention Description
CGM will be performed continously for 7 days
Primary Outcome Measure Information:
Title
ECG surrogate markers compared to cardiac events
Description
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)
Time Frame
Analysis will be performed after last patient is out
Secondary Outcome Measure Information:
Title
Continuous glucose monitoring is performed to identify episodes of hypoglycaemia
Description
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)
Time Frame
Analysis will be done after last patient is out

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikolaus Marx, Univ.-Prof.
Organizational Affiliation
Department of Internal Medicine University Hospital Aachen
Official's Role
Principal Investigator
Facility Information:
Facility Name
regioMed-Kliniken GmbH
City
Coburg
State/Province
Bayern
ZIP/Postal Code
96450
Country
Germany
Facility Name
University Hospital Würzburg
City
Würzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Facility Name
Department of Internal Medicine I University Hospital RWTH Aachen
City
Aachen
State/Province
NRW
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

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

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