Status:

COMPLETED

T-Wave Alternans in Dialysis Patients

Lead Sponsor:

Northwestern University

Collaborating Sponsors:

General Electric

Conditions:

Sudden Cardiac Death

End Stage Renal Disease

Eligibility:

All Genders

18-90 years

Brief Summary

Sudden cardiac death due to arrhythmia is the leading cause of death in end-stage renal disease (ESRD) patients treated with hemodialysis (HD). As it is anticipated that the number of individuals with...

Detailed Description

The purpose of this study is to assess the degree of cardiac electrical instability at various times in the dialysis cycle. The hypothesis is that longer time intervals between hemodialysis results in...

Eligibility Criteria

Inclusion

  • Patients with chronic ESRD who have been on HD for at least 3 months
  • Subjects 18 to 90 years of age with one or more risk factors for coronary artery disease or sudden cardiac death, including diabetes, peripheral vascular disease, known coronary artery disease, or ejection fraction \< 40% by any imaging modality.

Exclusion

  • Subjects unwilling or unable to give written informed consent.
  • Patients unable to return for regularly scheduled dialysis treatments
  • Atrial fibrillation or flutter at screening
  • Major surgical procedure two months prior to enrollment
  • High grade heart block or a permanent pacemaker in situ
  • Patients with known allergies to adhesive tape

Key Trial Info

Start Date :

April 1 2007

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

May 1 2008

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT00621426

Start Date

April 1 2007

End Date

May 1 2008

Last Update

March 12 2015

Active Locations (1)

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Northwestern University

Chicago, Illinois, United States, 60611