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
  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

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

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

No publications provided

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:
hemodialysis
sudden cardiac death

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

ClinicalTrials.gov processed this record on August 28, 2014