NCT02001480|Completed
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Sponsor study identifier
interventional
60
1 country
3
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2015
Actual (reported)Study Completion
December 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
October 23, 2013
Actual (reported)December 5, 2013
Actual (reported)December 2015
Actual (reported)December 2015
Actual (reported)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)
Analysis will be performed after last patient is out
Continuous glucose monitoring is performed to identify episodes of hypoglycaemia
Analysis will be done after last patient is out
12 lead holter for 7 days CGM = continuous Glucose Monitoring
12 lead Holter measurements will be performed for 7 days
CGM will be performed continously for 7 days
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
regioMed-Kliniken GmbH
Coburg, Bavaria, 96450, Germany
University Hospital Würzburg
Würzburg, Bavaria, 97080, Germany
Department of Internal Medicine I University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, 52074, Germany
Nikolaus Marx, Univ.-Prof.
Department of Internal Medicine University Hospital Aachen
60 participants (actual enrollment reported by the registry).
First Submitted
October 23, 2013
First Posted
December 5, 2013
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
Individualized Lifestyle Intervention in Subjects With Prediabetes
Contact the study team to confirm eligibility.
Primary Completion
December 2015
Actual (reported)Study Completion
December 2015
Actual (reported)Last Updated
January 20, 2016
Record last verified: 2016-01
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Source: ClinicalTrials.gov.
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