T-Wave Alternans in Dialysis Patients

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.

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Key information

Conditions

Sudden Cardiac Death Cardiovascular Diseases Chronic Disease Death Death, Sudden Death, Sudden, Cardiac Disease Attributes End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Arrest Heart Diseases Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Measure the degree of cardiac electrical instability at various times in the dialysis cycle.

Time frame: Basline, during dialysis

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

General Electric

Registry information

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Feb 22, 2008
Registry last updated: Mar 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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