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T Wave Alternans in Hemodialysis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00296543
First Posted: February 27, 2006
Last Update Posted: June 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Dialysis Clinic, Inc.
Information provided by:
Indiana University
  Purpose
The purpose of this study is to determine if the hemodialysis procedure changes the risk for cardiac arrest in patients.

Condition
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hemodialysis patients with heart disease and/or poor cardiac function
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00296543


Locations
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46032
Sponsors and Collaborators
Indiana University School of Medicine
Dialysis Clinic, Inc.
Investigators
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
First Submitted: February 23, 2006
First Posted: February 27, 2006
Last Update Posted: June 20, 2011
Last Verified: June 2011

Keywords provided by Indiana University:
hemodialysis
sudden cardiac death

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