Long-term intermittent dobutamine infusion, combined with oral amiodarone for end-stage heart failure: a randomized double-blind study.

STUDY OBJECTIVES

To examine the effects of long-term intermittent dobutamine infusion, combined with oral amiodarone in patients with congestive heart failure (CHF) refractory to standard medical treatment.

DESIGN

Prospective, randomized, double-blind, placebo-controlled clinical trial.

SETTING

Inpatient and outpatient heart failure clinic in a university teaching hospital.

PATIENTS AND INTERVENTIONS

Thirty patients with end-stage CHF refractory to standard medical treatment who could be weaned from dobutamine therapy after a first 72-h infusion were randomized in a double-blind manner to receive IV infusions of placebo (group 1; 14 patients) vs dobutamine in a dose of 10 micro g/kg/min (group 2; 16 patients) for 8 h every 14 days. All patients received standard medical therapy and also were treated with oral amiodarone, 400 mg/d, which was started at least 2 weeks before randomization.

MEASUREMENTS AND RESULTS

Kaplan-Meier survival analysis showed a 60% reduction in the risk of death from any cause in the group treated with the combination of dobutamine and amiodarone, compared with the group treated with placebo and amiodarone (hazard ratio, 0.403; 95% confidence interval, 0.164 to 0.992; p = 0.048). The 1-year and 2-year survival rates were 69% and 44%, respectively, in the dobutamine-treated group, vs 28% and 21%, respectively, in the placebo-treated group (p < 0.05 for both comparisons). Median survival times were 574 and 144 days, respectively, for groups 2 and 1. At 6 months, the New York Heart Association functional class was significantly improved in the patients who survived from both groups.

CONCLUSIONS

Long-term intermittent dobutamine infusion combined with amiodarone added to the conventional drugs improved the survival of patients with advanced CHF that was refractory to conventional treatment.