Prognostic Significance of T Wave Alternans

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.

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Key information

Conditions

Heart Diseases Arrhythmias, Cardiac Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Pathologic Processes Pathological Conditions, Signs and Symptoms Ventricular Arrhythmia Ventricular Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University

New York, 10023, United States

About this study

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) 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with left ventricular dusfunction
Patients with non-ischemic cardiomyopathy

Exclusion criteria

Patients not at high risk for sudden cardiac death (SCD)

Treatment and study plan

ECG

Procedure

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

Other names: Electrocardiogram

Primary outcomes

Pevalence of SCD with earlier testing that indicated TWA

Time frame: Up to 24 months

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

The Prevalence and Prognostic Significance of T Wave Alternans in Patients With Severe Congestive Heart Failture

Important dates

Study start: 2003
Primary completion: 2009
Study completion: 2012
First posted: Nov 17, 2000
Registry last updated: Dec 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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