Placebo-controlled study of oral enoximone in congestive heart failure with initial and final intravenous hemodynamic evaluation.

Seventeen patients with stable congestive heart failure (class II and III New York Heart Association) received intravenous and oral enoximone in a 2-part study. Hemodynamic data were first obtained after intravenous administration of 0.75 mg/kg of enoximone; data were again obtained after 12 weeks of therapy with either oral enoximone (150 mg 3 times daily) or placebo. The efficacy and safety of oral enoximone were also studied in a 12-week, double-blind randomized format. In the intravenous study, enoximone was delivered over 5 minutes and hemodynamic data were measured for up to 12 hours after. Cardiac index increased 2.76 +/- 0.63 to 3.42 +/- 0.72 liters/min/m2), pulmonary wedge pressure decreased (19.5 +/- 8.8 to 14.6 +/- 8.0 mm Hg) as did mean arterial blood pressure (101 +/- 14.8 to 85 +/- 13.7 mm Hg) and systemic vascular resistance (1,880 +/- 573 to 1,254 +/- 383 dynes s cm-5). Heart rate increased slightly (82 +/- 17 to 86 +/- 14 beats/min). All these changes were maximal 1 to 2 hours after infusion and lasted 8 hours at least. Patients were then randomized double-blind to oral treatment. Baseline values showed that the 7 patients who received placebo had more severe CHF. Therefore, comparison might be biased. Patient overall assessment showed a continuous benefit in both groups. Ejection fraction improved from 30.1 +/- 6.8% to 33.9 +/- 9.9% in the enoximone group while it remained unchanged with placebo (23.4 +/- 6.5% to 23.4 +/- 1.5%).(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes