T Wave Alternans in Hemodialysis

This study has been completed.
Dialysis Clinic, Inc.
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
First received: February 23, 2006
Last updated: June 17, 2011
Last verified: June 2011
The purpose of this study is to determine if the hemodialysis procedure changes the risk for cardiac arrest in patients.

End Stage Renal Disease
Coronary Heart Disease
Congestive Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of a Noninvasive Predictor of Sudden Cardiac Death in Hemodialysis Patients

Resource links provided by NLM:

Further study details as provided by Indiana University:

Estimated Enrollment: 30
Study Start Date: October 2005
Study Completion Date: August 2008
Detailed Description:
One-third to one-quarter of hemodialysis patients die of sudden cardiac death (SCD). The hemodialysis procedure may theoretically increase the risk of SCD. This study uses T wave alternans, a noninvasive marker of SCD, to objectively determine whether the hemodialysis procedure alters the risk of SCD in hemodialysis patients.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hemodialysis patients with heart disease and/or poor cardiac function

Inclusion Criteria:

  • 18 years of age or older
  • Normal sinus rhythm

Exclusion Criteria:

  • Inability to give written informed consent
  • Active cardiac ischemia
  • Pacemaker
  • Inability to perform a brief walking treadmill test
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00296543

United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46032
Sponsors and Collaborators
Indiana University School of Medicine
Dialysis Clinic, Inc.
Principal Investigator: Allon Friedman, MD Indiana University School of Medicine
  More Information

Responsible Party: Allon Friedman, MD, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00296543     History of Changes
Other Study ID Numbers: 0508-02 
Study First Received: February 23, 2006
Last Updated: June 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
sudden cardiac death

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Death, Sudden, Cardiac
Heart Failure
Kidney Failure, Chronic
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Death, Sudden
Heart Arrest
Heart Diseases
Kidney Diseases
Pathologic Processes
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 02, 2016