Evaluation of a new inotropic agent, OPC-8212, in patients with dilated cardiomyopathy and heart failure.

OPC-8212 is a new positive inotrope with a unique mechanism of action. To assess its clinical utility we administered 60 mg/day for 30 days to 10 patients with overt congestive heart failure, who had substantial limitations in exercise performance despite treatment with conventional therapy. Patients were evaluated by simultaneous respiratory gas exchange and radionuclide ventriculography measurements during graded maximal exercise testing. Improvement was demonstrated in both peak oxygen uptake and radionuclide-determined cardiac index after 30 days of treatment with OPC-8212. These changes were not associated with alterations in heart rate at rest or during peak exercise. Furthermore OPC-8212 significantly decreased ventricular ectopy in our patients. However, two patients had possible hematologic toxicity with prolonged use. The results of the present phase II study suggest that a larger randomized double-blind placebo study to evaluate the safety and clinical efficacy of this drug is warranted.

RCT Entities:   Population Interventions Outcomes