Title of Trial
T Wave Alternans in Congestive Heart Failure (TWA in CHF) trial

Date and Location of Presentation
Presented at the late-breaking clinical trials of the American College of Cardiology Annual Scientific Sessions 2003 in Chicago, Illinois

Date and citation of primary publication(s) or References
Not Published

Purpose of the Trial
The aim of the TWA in CHF trial was to determine if TWA is associated with an increased risk of arrhythmic event in heat failure patients with left ventricular dysfunction and no prior arrhythmic events.

Study Category
Sudden Cardiac Death & Syncope

Patient Population
Heart failure patients with reduced left ventricular ejection fraction

Inclusion Criteria

• Left ventricular ejection fraction < 0.40
• No history of arrhythmic events
• Age > 18 years

Exclusion Criteria

• Unstable coronary artery disease
• Class IV NYHA for heart failure
• Persistent atrial arryhythmias

Study Design
Non-randomized trial

Primary Endpoints
Arrhythmic death and non-fatal cardiac arrest

Secondary Endpoints
All-cause mortality

Baseline Characteristics
Patient number: 542 patients
Mean Age: 56 years
Gender: % female; 29%
Other characteristics: Mean ejection fraction was 0.25 ± 0.9 and 61% of patients had an EF <30%. NYHA Class (% I, II, II, IV): NYHA II (52%) and III (28%)

Time to Follow-up
12.2 months

Results
The TWA test was positive in 30%, negative in 34%, and indeterminate in the remaining 36%. All-cause mortality at two years was higher in TWA positive patients versus TWA negative patients (hazard ratio [HR] = 9.7, log rank p<0.01). Among patients who were TWA negative and had an ejection fraction (EF) <30% (n=78), only one death occurred during follow-up. In a model adjusting for EF, positive TWA remained associated with mortality (HR = 8.4, p<0.01).

Trial Status: Completed

Review written by Samir Saba, MD