Prognostic Significance of T Wave Alternans

NCT00006501 | Completed

• 2 other identifiers: AAAB1399R01HL064862
• Study Type: observational
• Target: 549
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Pevalence of SCD with earlier testing that indicated TWA

  Up to 24 months

Study Arms (1)

ECG recording

After the tests are completed, people who enroll in this study are followed by telephone, 1, 4, 8, 12 16, 20 and 24 months. During these follow-up telephone calls a research coordinator asks about the participant's health condition and about cardiovascular medications that are being taken.

Procedure: ECG

Interventions

ECG PROCEDURE

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

Also known as: Electrocardiogram

ECG recording

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with left ventricular dusfunction or non-ischemic cardiomyopathy, and are at high risk for sudden cardiac death.

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)

Sponsors & Collaborators

• Columbia University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Columbia University

New York, New York, 10023, United States

Location

Related Publications (1)

• Bloomfield DM, Bigger JT, Steinman RC, Namerow PB, Parides MK, Curtis AB, Kaufman ES, Davidenko JM, Shinn TS, Fontaine JM. Microvolt T-wave alternans and the risk of death or sustained ventricular arrhythmias in patients with left ventricular dysfunction. J Am Coll Cardiol. 2006 Jan 17;47(2):456-63. doi: 10.1016/j.jacc.2005.11.026. Epub 2005 Dec 15.

  PMID: 16412877 BACKGROUND

MeSH Terms

Conditions

Heart Diseases; Ventricular Fibrillation; Death, Sudden, Cardiac; Heart Arrest

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Death, Sudden; Death

Study Officials

• John Bigger

  Professor Emeritus of Medicine and Pharmacology, Columbia University

  PRINCIPAL INVESTIGATOR

• John Bigger

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2000
• First Posted: November 17, 2000
• Study Start: January 1, 2003
• Primary Completion: December 1, 2009
• Study Completion: February 1, 2012
• Last Updated: December 23, 2015

Record last verified: 2015-12

Locations

US (1)