Randomized Trial of Low-Dose Amiodarone in Severe Congestive Heart failure - GESICA

Feb 01, 2002
Font Size
A
A
A
Date Published:
01/01/1994
Date Updated:
02/01/2002
Original Posted Date:
02/01/2002
References

Description:

Amiodarone vs. placebo for mortality in severe congestive heart failure.

Hypothesis:

Low dose Amiodarone added to standard therapy reduces mortality in severe congestive heart failure.

Study Design

Study Design:

Patients Screened: Not given
Patients Enrolled: 516
Mean Follow Up: 13 months (24 months)
Mean Patient Age: 59
Female: 19
Mean Ejection Fraction: 20%

Patient Populations:

Severe congestive heart failure treated with:
Low sodium diet
Diuretics
Digoxin
Vasodilators
Low ejection or increased cardiothoracic ratio or increased left ventricular end diastolic diameter by echocardiogram.

Exclusions:

Antiarrhythmic treatment
Amiodarone treatment within the last 3 months
Thyroid disease
Respiratory failure
Other serious co-morbidity
Valvular disease
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

Primary Endpoints:

Total mortality

Secondary Endpoints:

Subgroup mortality
Sudden death or death due to progressive heart failure
Hospital admission due to heart failure

Drug/Procedures Used:

Amiodarone 600 mg QD x 14 days and then 300 mg QD

Concomitant Medications:

Enalapril (90%)
Digoxin (76%)
Diuretics (91%)
Nitrates (34%)

Principal Findings:

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).

Interpretation:

"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)

References:

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


< Back to Listings