Randomized Trial of Low-Dose Amiodarone in Severe Congestive Heart failure - GESICA
Amiodarone vs. placebo for mortality in severe congestive heart failure.
Low dose Amiodarone added to standard therapy reduces mortality in severe congestive heart failure.
Patients Screened: Not given
Patients Enrolled: 516
Mean Follow Up: 13 months (24 months)
Mean Patient Age: 59
Mean Ejection Fraction: 20%
Severe congestive heart failure treated with:
Low sodium diet
Low ejection or increased cardiothoracic ratio or increased left ventricular end diastolic diameter by echocardiogram.
Amiodarone treatment within the last 3 months
Other serious co-morbidity
Hypertrophic or restrictive cardiomyopathy
Angina, myocardial infarction, heart failure, or syncope onset within past 3 months
AV node disease
History of sustained ventricular tachycardia
Asymptomatic ventricular tachycardia > 10 beats at a rate of > 100 beats per minute
Sudden death or death due to progressive heart failure
Hospital admission due to heart failure
Amiodarone 600 mg QD x 14 days and then 300 mg QD
Total mortality was reduced by Amiodarone by 28% (p = 0.024).
Risk reduction was the same for sudden death (benefit observed early) and progressive heart failure (p = 0.16).
Combined endpoint of death and hospitalizations for heart failure was reduced in Amiodarone group (risk reduction 31%; p = 0.0024).
High proportion of patients improved at least one functional class in Amiodarone group (p <0.03).
"Low dose Amiodarone proved to be an effective and reliable treatment, reducing mortality and hospital admission in patients with severe heart failure independently of the presence of complex ventricular arrhythmias." (From Abstract)
1. Lancet 1994;344:493-98. Final results
Keywords: Diet, Sodium-Restricted, Digoxin, Risk Reduction Behavior, Diuretics, Heart Failure, Hospitalization, Death, Sudden, Cardiac, Vasodilator Agents
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