The ALPHA study (T-wave alternans in patients with heart failure): rationale, design and endpoints

BACKGROUND: Sudden death and pump failure are the main causes of death in patients with heart failure. Patients with ischemic and non-ischemic cardiomyopathy are at similar risk of arrhythmic mortality; however, standard non-invasive and invasive tests are not routinely available for non-ischemic patients. T-wave alternans (TWA) has been proposed as a potential marker of susceptibility to ventricular tachycardia-fibrillation in several groups of patients. METHODS: The ALPHA study was designed to evaluate the independent predictive value of the measurement of microvolt TWA on the combined occurrence, after 18 months of follow-up, of cardiac death and life-threatening arrhythmias in a population of patients with non-ischemic dilated cardiomyopathy and NYHA class II and III. This is a multicenter prospective observational study. A total of 370 patients, with measurable TWA, will be enrolled during routine follow-up for heart failure treatment; a logbook will be used to collect basic information on the whole screened population. Patients will be enrolled during a 2-year period and will be followed up for 18 months. The primary endpoint of the study will be the combined incidence of cardiac death and life-threatening ventricular arrhythmias. The study will complete recruitment by mid 2004 and report in 2006.