Prognostic Significance of T Wave Alternans

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00006501
First received: November 16, 2000
Last updated: January 20, 2006
Last verified: January 2006
  Purpose

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


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

Study Type: Observational
Study Design: Observational Model: Natural History
Time Perspective: Longitudinal

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 2000
Estimated Study Completion Date: August 2005
Detailed Description:

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) 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.

DESIGN NARRATIVE:

The prospective epidemiologic pilot study included 549 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00006501

Sponsors and Collaborators
Investigators
Investigator: JT Bigger Columbia University Health Sciences
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00006501     History of Changes
Other Study ID Numbers: 942
Study First Received: November 16, 2000
Last Updated: January 20, 2006
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Death, Sudden
Heart Arrest
Heart Diseases
Ventricular Fibrillation
Death, Sudden, Cardiac
Cardiovascular Diseases
Pathologic Processes
Death

ClinicalTrials.gov processed this record on August 28, 2014