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The ALPHA study (T-wave alternans in patients with heart failure): rationale, design and endpoints
Jorge A Salerno-Uriarte1, Roberto F E Pedretti, Massimo Tritto
1Department of Cardiovascular Sciences, University of Insubria, Circolo Hospital and Macchi Foundation, Varese, Italy. Jorge.Salerno@ospedale.varese.it
Insights
Microvolt T-wave alternans (TWA) may predict cardiac death and arrhythmias in non-ischemic heart failure patients. This study evaluates TWA as a risk marker for sudden cardiac events in this population.
Area of Science:
- Cardiology
- Electrophysiology
- Heart Failure Research
Background:
- Sudden death and pump failure are primary concerns in heart failure patients.
- Non-ischemic cardiomyopathy patients face similar arrhythmic mortality risks as ischemic patients but lack routine diagnostic tests.
- T-wave alternans (TWA) is explored as a potential marker for ventricular tachycardia-fibrillation susceptibility.
Purpose of the Study:
- To assess the independent predictive value of microvolt T-wave alternans (TWA) measurement.
- To evaluate TWA's role in predicting cardiac death and life-threatening arrhythmias in non-ischemic dilated cardiomyopathy patients.
- To analyze outcomes in patients with NYHA class II and III heart failure.
Main Methods:
- The ALPHA study is a multicenter, prospective, observational trial.
- 370 patients with non-ischemic dilated cardiomyopathy and measurable TWA were enrolled.
- Patients were followed for 18 months to record cardiac death and life-threatening ventricular arrhythmias.
Main Results:
- The study aimed to report findings by 2006.
- Primary endpoint was the combined incidence of cardiac death and life-threatening ventricular arrhythmias.
- Data collection involved a logbook for screened patients.
Conclusions:
- Microvolt T-wave alternans shows potential as a prognostic marker in heart failure.
- Further research is needed to establish TWA's clinical utility in non-ischemic cardiomyopathy.
- The findings contribute to understanding arrhythmic risk stratification in heart failure.
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.
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