T-Wave Alternans in Dialysis Patients

End Stage Renal Disease Clinical Trial

Official title:

T-Wave Alternans in Dialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00621426
• Other study ID #: 0388-010
• Status: Completed
• Phase: N/A
• First received: February 12, 2008
• Last updated: March 11, 2015
• Start date: April 2007
• Est. completion date: May 2008

Study information

• Verified date: March 2015
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Sudden Cardiac Death

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	General Electric

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the degree of cardiac electrical instability at various times in the dialysis cycle.		Basline, during dialysis	No