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Home > "P" Clinical Trials Conditions > Prognostic Significance of T Wave Alternans  Prognostic Significance of T Wave Alternans
Prognostic Significance of T Wave Alternans
For Condition: Ventricular Arrhythmia,Heart Diseases,Ventricular Fibrillation,Heart Arrest,Death, Sudden, Cardiac
Status: No longer recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To evaluate whether T Wave Alternans can predict ventricular arrhythmias and sudden cardiac death in a prospective epidemiologic natural history study.
Details: BACKGROUND: Sudden cardiac death accounts for approximately 400,000 deaths each year in the United States and remains a health problem of epidemic proportions. Most sudden cardiac deaths are caused by fatal ventricular arrhythmias. An effort aimed at the primary prevention of sudden cardiac death requires efficient identification of patients who are at high enough risk for having these arrhythmias to warrant aggressive prophylactic therapy. A number of recently completed, randomized clinical trials have demonstrated that an implantable cardiac defibrillator (ICD) can prevent sudden cardiac death in a highly selected group of high-risk patients. When these trials are viewed together, the only patients in whom the prophylactic implantation of an ICD has proven benefit are those patients identified by documented, spontaneous or inducible, sustained ventricular arrhythmias. Two randomized treatment trials (MADIT II, SCD-HEFT) are currently testing the hypothesis that implantation of an ICD will reduce mortality in patients with congestive heart failure (CHF) and left ventricular dysfunction without any further risk stratification. However, the implications of these two trials-implantation of an ICD in every patient with CHF-are unlikely to be accepted either by the medical community or by health care payers. More efficient methods of risk stratification will be necessary to identify those patients with CHF who are most likely to benefit from prophylactic treatment with an ICD. T Wave Alternans is a subtle every-other-beat variation in electrocardiographic T waves that is prognostic of patients at high risk for life-threatening cardiac arrhythmias and sudden cardiac death. It has recently been shown that T Wave Alternans (TWA) measured during exercise is strongly associated with inducible monomorphic CVT and with subsequent spontaneous arrhythmic events. This preliminary data suggest that TWA may be an efficient and non-invasive surrogate for electrophysiologic testing to screen patients who may be at high-risk for sudden cardiac death. DESIGN NARRATIVE: The prospective epidemiologic pilot study includes approximately 400 patients that have left ventricular dysfunction and no history of sustained ventricular arrhythmias. The primary hypothesis to be tested is whether there is an increased risk of having an arrhythmic event when T Wave Alternans is present in the patient. The secondary aims include comparing risk due to T Wave Alternans between the ischemic patients and non-ischemic patients and assessing whether T Wave Alternans remains 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 is a standard epidemiologic surveillance technique. The subject population consists of individuals with Class I to III heart failure who will undergo a TWA and Holter monitor test and then are followed for up to two years, or age 51, or until arrhythmic events occur.
Eligibility:
Study Type: Observational, Natural History, Longitudinal
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: No eligibility criteria
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DanielBloomfield, , Columbia University Health Sciences
Additional Information:
Study ID Numbers: 942;
Study Start Date: September 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006501
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Prognostic Significance of T Wave Alternans
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