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.