Estudio Piloto Argentino de Muerte Subita y Amioda rone (Argentine Pilot Study of Sudden Death and Amiodarone) - EPAMSA


Amiodarone for 1-year mortality in patients with reduced LV function.


Amiodarone will reduce sudden death by 50%, and therefore overall mortality by 25%, in patients with poor ventricular function and asymptomatic complex ventricular arrhythmias (ACVA).

Study Design

Study Design:

Patients Screened: Not given
Patients Enrolled: 106
Mean Follow Up: 12 months
Mean Patient Age: 61 ± 9 years
Female: Amiodarone = 18%; control group = 27%
Mean Ejection Fraction: 27 ± 7%

Patient Populations:

Age 40 to 75 years
Left ventricular ejection fraction at rest < 35%
ACVA without clinical heart failure or electrolyte abnormalities
Results of routine laboratory analysis within normal limits


Requirement for antiarrhythmic therapy as determined by the physician
Clinical instability (acute myocarditis, unstable angina, acute myocardial infarction (MI), or cardiac surgery in the preceding 3 months, cardiac failure decompensation or terminal disease)
Contraindications for the use of amiodarone

Primary Endpoints:

Sudden death
Congestive heart failure death
Other cardiac death
Noncardiac death

Drug/Procedures Used:

Amiodarone, 800 mg/day for 2 weeks, 400 mg/day thereafter for 12 months

Concomitant Medications:

Vasodilators, mainly angiotensin-converting enzyme inhibitors (88%)

Principal Findings:

Amiodarone reduced the overall mortality rate (10.5% vs 28.6% in control group; odds ratio 0.29; 95% confidence interval [CI] 0.19 to 0.84; log-rank test 0.02)

Amiodarone also reduced the sudden-death rate (7.0%% vs 20.4% in control group; odds ratio 0.29; 95% CI 0.08 to 1.00; log-rank test 0.04)

Side effects were rare; in only 3 patients did amiodarone treatment have to be discontinued.


Amiodarone treatment was associated with a 71% reduction in overall and sudden death mortality at 1 year in patients with poor ventricular function and ACVA of diverse causes. Nevertheless, because the sample was small, these findings required further confirmation in more extensive randomized trials.


1. Am Heart J 1995;130:494-500. Final results

Clinical Topics: Arrhythmias and Clinical EP, Heart Failure and Cardiomyopathies, SCD/Ventricular Arrhythmias, Acute Heart Failure

Keywords: Tachycardia, Ventricular, Ventricular Fibrillation, Heart Failure, Stroke Volume, Ventricular Function, Death, Sudden, Cardiac

< Back to Listings