T-Wave Alternans in Dialysis Patients

NCT00621426 | Completed

• 1 other identifier: 0388-010
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

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

  Basline, during dialysis

Study Arms (1)

Observation

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• General Electric: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Death, Sudden, Cardiac; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Rod Passman, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2008
• First Posted: February 22, 2008
• Study Start: April 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: March 12, 2015

Record last verified: 2015-03

Locations

US (1)