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Prognostic Significance of T Wave Alternans

NCT00006501 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 549

Last updated 2015-12-23

No results posted yet for this study

Summary

To evaluate whether T Wave Alternans can predict ventricular arrhythmias and sudden cardiac death (SCD) in a prospective epidemiologic natural history study.

The prospective epidemiologic pilot study included 550 patients that had left ventricular dysfunction and no history of sustained ventricular arrhythmias. The primary hypothesis tested was whether there was an increased risk of having an arrhythmic event when T Wave Alternans was present in the patient. The secondary aims included comparing risk due to T Wave Alternans between the ischemic patients and non-ischemic patients and assessing whether T Wave Alternans remained an independent predictor of risk upon adjustment for other known risk factors for arrhythmic events such as ejection fraction, ventricular ectopy, NSVT, average NN interval, and RR interval variability.

The study approach was a standard epidemiologic surveillance technique. The subject population consisted of individuals with Class I to III heart failure who will underwent a TWA and Holter monitor test and then were followed for up to two years or until arrhythmic events occured.

Conditions

  • Heart Diseases
  • Ventricular Arrhythmia
  • Ventricular Fibrillation
  • Death, Sudden, Cardiac
  • Heart Arrest

Interventions

PROCEDURE

ECG

A diagnostic tool that is routinely used to assess the electrical and muscular functions of the heart (non-experimental).

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Columbia University

    lead OTHER

Principal Investigators

  • John Bigger · Professor Emeritus of Medicine and Pharmacology, Columbia University

  • John Bigger · Columbia University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2009-12-31
Completion
2012-02-29

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00006501 on ClinicalTrials.gov