A placebo-controlled, randomized, double-blind study of OPC-8212 in patients with mild chronic heart failure. OPC-8212 Multicenter Research Group.

OPC-8212 is a newly synthesized, orally effective inotropic agent. Previous studies have shown short-term hemodynamic and symptomatic improvement in patients with congestive heart failure. However, the long-term efficacy of this agent remains to be established. Eighty-three patients with chronic heart failure were randomly assigned to treatment with either OPC-8212 (n = 45) or matching placebo (n = 38). Of the placebo-treated patients, two patients died and another six patients were withdrawn from the study because of a deterioration of heart failure, while only 1 out of 45 OPC-8212-treated patients were withdrawn because of increased congestive symptoms. After 12 weeks of treatment, the OPC-8212 group showed a significant improvement in their numerical scores in sense of well-being as judged by the patients subscale A (p less than 0.01) and their physicians' general impression of the patients' status (p less than 0.01). The ejection fraction obtained from echocardiography increased from a mean (+/- SEM) baseline value of 42.8 +/- 2.6% to 46.6 +/- 2.9% (p less than 0.05) in the OPC-8212 group and 44.4 +/- 3.7% to 45.5 +/- 4.1% in the placebo group. These effects were not associated with an increase in the heart rate. The treatment was well tolerated without any limiting side effects. Thus, OPC-8212 is effective in patients with chronic heart failure, providing significant hemodynamic and symptomatic benefit in chronic treatment, together with a possible improvement of the prognosis of patients with heart failure.

RCT Entities:   Population Interventions Outcomes