T-Wave Alternans in Dialysis Patients - Full Text View

Sponsors and Collaborators:	Northwestern University General Electric
Information provided by:	Northwestern University
ClinicalTrials.gov Identifier:	NCT00621426

Purpose

Sudden cardiac death due to arrhythmia is the leading cause of death in end-stage renal disease (ESRD) patients treated with hemodialysis (HD). As it is anticipated that the number of individuals with ESRD will exceed 1.2 million in the next 20 years, sudden death in this population has enormous public health impact. Research has shown that arrhythmic events are temporally associated with longer periods between HD with a three-fold risk of events in the 12 hours preceding the longest inter-dialysis interval. The exact cause of these findings is unknown.

Condition
Sudden Cardiac Death End Stage Renal Disease

MedlinePlus related topics: Cardiac Arrest

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	T-Wave Alternans in Dialysis Patients

Further study details as provided by Northwestern University:

Primary Outcome Measures:

Measure the degree of cardiac electrical instability at various times in the dialysis cycle. [ Time Frame: Basline, during dialysis ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	40
Study Start Date:	April 2007
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
Observation Patients with end-stage renal disease (ESRD) treated with hemodialysis three (3) times per week for at least 3 continuous months

Detailed Description:

The purpose of this study is to assess the degree of cardiac electrical instability at various times in the dialysis cycle. The hypothesis is that longer time intervals between hemodialysis results in sympathetic and electrolyte-induced alterations in ventricular repolarization that can be measured non-invasively using microvolt T-wave alternans (TWA). This increase in cardiac electrical instability may serve as a link between the clinically observed periods of increased risk and the occurrence of sudden cardiac death.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with end-stage renal disease (ESRD) treated with hemodialysis three (3) times per week for at least 3 continuous months will be enrolled. No limitations for gender, race, socioeconomic status or any other parameters will be applied.

Criteria

Inclusion Criteria:

Patients with chronic ESRD who have been on HD for at least 3 months
Subjects 18 to 90 years of age with one or more risk factors for coronary artery disease or sudden cardiac death, including diabetes, peripheral vascular disease, known coronary artery disease, or ejection fraction < 40% by any imaging modality.

Exclusion Criteria:

Subjects unwilling or unable to give written informed consent.
Patients unable to return for regularly scheduled dialysis treatments
Atrial fibrillation or flutter at screening
Major surgical procedure two months prior to enrollment
High grade heart block or a permanent pacemaker in situ
Patients with known allergies to adhesive tape

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621426

Locations

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

General Electric

Investigators

Principal Investigator:

Rod Passman, MD

Northwestern University

More Information

No publications provided

Responsible Party:	Northwestern University ( Rod Passman, MD )
Study ID Numbers:	0388-010
Study First Received:	February 12, 2008
Last Updated:	May 31, 2008
ClinicalTrials.gov Identifier:	NCT00621426 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Northwestern University:

T wave alternans (TWA)
dialysis
end stage renal disease
sudden cardiac death

T-wave alternans
Cardiac electrical instability
Sympathetic and electrolyte-induced alterations
Ventricular repolarization

Study placed in the following topic categories:

Renal Insufficiency
Death
Heart Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Death, Sudden

Kidney Failure, Chronic
Heart Arrest
Death, Sudden, Cardiac
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Death
Renal Insufficiency
Heart Diseases
Kidney Failure, Chronic
Heart Arrest
Pathologic Processes
Urologic Diseases

Renal Insufficiency, Chronic
Death, Sudden
Cardiovascular Diseases
Kidney Diseases
Death, Sudden, Cardiac
Kidney Failure

ClinicalTrials.gov processed this record on May 06, 2009