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T-Wave Alternans in Dialysis Patients

This study has been completed.
Sponsor:
Collaborator:
General Electric
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00621426
First received: February 12, 2008
Last updated: September 16, 2010
Last verified: September 2010
History of Changes
  Purpose

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.


Condition
Sudden Cardiac Death
End Stage Renal Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: T-Wave Alternans in Dialysis Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Measure the degree of cardiac electrical instability at various times in the dialysis cycle. [ Time Frame: Basline, during dialysis ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: April 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observation
Patients with end-stage renal disease (ESRD) treated with hemodialysis three (3) times per week for at least 3 continuous months

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00621426

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
General Electric
Investigators
Principal Investigator: Rod Passman, MD Northwestern University
  More Information

No publications provided

Responsible Party: Rod Passman, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00621426     History of Changes
Other Study ID Numbers: 0388-010
Study First Received: February 12, 2008
Last Updated: September 16, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
T wave alternans (TWA)
dialysis
end stage renal disease
sudden cardiac death
 T-wave alternans
Cardiac electrical instability
Sympathetic and electrolyte-induced alterations
Ventricular repolarization

Additional relevant MeSH terms:
Death
Kidney Diseases
Kidney Failure, Chronic
Death, Sudden, Cardiac
Pathologic Processes
Urologic Diseases
 Renal Insufficiency, Chronic
Renal Insufficiency
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden

ClinicalTrials.gov processed this record on May 23, 2013