T-Wave Alternans in Dialysis Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00621426

Enrollment

Registered

2008-02-22

Start date

2007-04-30

Completion date

2008-05-31

Last updated

2015-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease, Sudden Cardiac Death

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Measure the degree of cardiac electrical instability at various times in the dialysis cycle.	Basline, during dialysis

Countries

United States

Outcome results