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T Wave Alternans in Hemodialysis

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.
ClinicalTrials.gov Identifier: NCT00296543
Recruitment Status : Completed
First Posted : February 27, 2006
Last Update Posted : June 20, 2011
Sponsor:
Collaborator:
Dialysis Clinic, Inc.
Information provided by:
Indiana University

Brief Summary:
The purpose of this study is to determine if the hemodialysis procedure changes the risk for cardiac arrest in patients.

Condition or disease
End Stage Renal Disease Coronary Heart Disease Congestive Heart Failure

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.

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of a Noninvasive Predictor of Sudden Cardiac Death in Hemodialysis Patients
Study Start Date : October 2005
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources





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

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

Responsible Party: Allon Friedman, MD, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00296543     History of Changes
Other Study ID Numbers: 0508-02
First Posted: February 27, 2006    Key Record Dates
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