Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006501
Status:
COMPLETED
Last Update Posted:
2015-12-23
First Post:
2000-11-16
Brief Title:
Prognostic Significance of T Wave Alternans
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
The Prevalence and Prognostic Significance of T Wave Alternans in Patients With Severe Congestive Heart Failture
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Sudden cardiac death accounts for approximately 400000 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 tested the hypothesis that implantation of an ICD would reduce mortality in patients with congestive heart failure CHF and left ventricular dysfunction without any further risk tratification However the implications of these two trials-implantation of an ICD in every patient with CHF-were unlikely to be accepted either by the medical community or by health care payers More efficient methods of risk stratification were necessary to identify those patients with CHF who were 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
Two randomized treatment trials MADIT II SCD-HEFT tested the hypothesis that implantation of an ICD would reduce mortality in patients with congestive heart failure CHF and left ventricular dysfunction without any further risk tratification However the implications of these two trials-implantation of an ICD in every patient with CHF-were unlikely to be accepted either by the medical community or by health care payers More efficient methods of risk stratification were necessary to identify those patients with CHF who were 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL064862 | NIH | None | httpsreporternihgovquickSearchR01HL064862 |