Rationale and design of the OPTIME CHF trial: Outcomes of a prospective trial of intravenous milrinone for exacerbations of chronic heart failure

Background The optimal management of an acute exacerbation of chronic heart failure (CHF) is uncertain. There is little randomized evidence available to support the various treatment strategies for patients hospitalized with an exacerbation of CHF. Inotropic agents may produce beneficial hemodynamic effects, and although they are currently used in these patients, their eff ect on clinical response and impact on clinical outcome is unclear. We pres ent a unique and simple study designed to determine whether a treatment str ategy for CHF exacerbations that includes an intravenous agent with inotrop ic properties can reduce hospital length of stay and lead to improved patie nt outcome. Methods The OPTIME CHF (Outcomes of a Prospective Trial of Intravenous Milr inone for Exacerbations of Chronic Heart Failure) trial is an ongoing multi center, randomized, placebo-controlled trial of a treatment strategy for pa tients with acute exacerbations of CHF. The design of this study provides a novel approach to the evaluation of treatment strategies in the care of th is population. The OPTIME CHF design uses early initiation of intravenous m ilrinone as both on adjunct to the best the medical therapy and to facilita te optimal dosing of standard oral therapy for heart failure. Patients with known systolic heart failure requiring hospital admission for a CHF exacer bation are randomly assigned within 48 hours of admission to receive a 48-h our infusion of either intravenous milrinone or placebo. The primary end po int of this design is a reduction in the total hospital days for cardiovasc ular events within 60 days after therapy. Enrollment of 1000 patients began July 7, 1997, at 80 US centers and is projected to conclude in late 1999.