T-Wave Alternans in Dialysis Patients

March 11, 2015 updated by: Rod Passman, Northwestern University
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 ESRD will exceed 1.2 million in the next 20 years, sudden death in this population has enormous public health impact. Research has shown that arrhythmic events are temporally associated with longer periods between HD with a three-fold risk of events in the 12 hours preceding the longest inter-dialysis interval. The exact cause of these findings is unknown.

Study Overview

Status

Completed

Conditions

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 sympathetic and electrolyte-induced alterations in ventricular repolarization that can be measured non-invasively using microvolt T-wave alternans (TWA). This increase in cardiac electrical instability may serve as a link between the clinically observed periods of increased risk and the occurrence of sudden cardiac death.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with end-stage renal disease (ESRD) treated with hemodialysis three (3) times per week for at least 3 continuous months will be enrolled. No limitations for gender, race, socioeconomic status or any other parameters will be applied.

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Observation
Patients with end-stage renal disease (ESRD) treated with hemodialysis three (3) times per week for at least 3 continuous months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure the degree of cardiac electrical instability at various times in the dialysis cycle.
Time Frame: Basline, during dialysis
Basline, during dialysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

General Electric

Investigators

  • Principal Investigator: Rod Passman, MD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

February 12, 2008

First Submitted That Met QC Criteria

February 21, 2008

First Posted (Estimate)

February 22, 2008

Study Record Updates

Last Update Posted (Estimate)

March 12, 2015

Last Update Submitted That Met QC Criteria

March 11, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0388-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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