T Wave Alternans in Hemodialysis

This study has been completed.

Sponsor:

Collaborator:

Dialysis Clinic, Inc.

Information provided by:

Indiana University

ClinicalTrials.gov Identifier:

NCT00296543

First received: February 23, 2006

Last updated: June 17, 2011

Last verified: June 2011

History of Changes

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:

MedlinePlus related topics: Dialysis

U.S. FDA Resources

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


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	February 23, 2006
Last Updated:	June 17, 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

ClinicalTrials.gov processed this record on July 19, 2017

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