Clinical trial NCT00621426: T-Wave Alternans in Dialysis Patients
Official title: T-Wave Alternans in Dialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sudden Cardiac Death
End Stage Renal Disease
Keywords: 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
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: General Electric
First posted: 2008-02-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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 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

Primary outcomes:
measure: Measure the degree of cardiac electrical instability at various times in the dialysis cycle.
timeFrame: Basline, during dialysis
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Rod Passman, MD
role: PRINCIPAL_INVESTIGATOR
References: