Prognostic Significance of T Wave Alternans
Completed
Conditions studied: Heart Diseases, Ventricular Arrhythmia, Ventricular Fibrillation, Death, Sudden, Cardiac, Heart Arrest
In brief
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.
Key facts
- Study ID
- NCT00006501
- Run by
- Columbia University
- People needed
- 549
- Starts
- 2003-01-01
- Expected to finish
- 2012-02-01
- Last updated by the study team
- 2015-12-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with left ventricular dusfunction
- Patients with non-ischemic cardiomyopathy
You may not qualify if…
- Patients not at high risk for sudden cardiac death (SCD)
Where it is running
- Columbia University — New York, New York, United States
Full record on ClinicalTrials.gov
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