Rationale and Design of a Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of B-Type Natriuretic Peptide for the Preservation of Left Ventricular Function After Anterior Myocardial Infarction

Background: B-type natriuretic peptide (BNP) is a hormone with pleiotropic cardioprotective properties. Previously in our non-placebo-controlled non-blinded pilot study (BELIEVE) in human ST-segment-elevation anterior acute myocardial infarction (AMI), a 72-hour intravenous (IV) infusion of recombinant human BNP (nesiritide) at a dose of 0.006 mu g kg(-1) min(-1) suppressed plasma aldosterone, reduced cardiac dilatation, and improved left ventricular (LV) ejection fraction (LVEF) at 1 month compared with baseline. Methods and Design: The BELIEVE II study is a phase II, randomized, double-blind, placebo-controlled, single-center clinical trial to assess the efficacy of 72-hour IV infusion of nesiritide therapy (0.006 mu g kg(-1) min(-1)) in humans with first-time ST-segment-elevation anterior AMI and successful reperfusion, in preventing adverse LV remodeling and preserving LV function. A total of 60 patients will be randomized to placebo or nesiritide therapy. The primary efficacy end point is LV end-systolic and end-diastolic dimensions determined by multiple gated acquisition scan between placebo and nesiritide groups at 30 days; secondary end points include 30-day LVEF, diastolic function, infarct size, LV mass, and combined total mortality and heart failure hospitalization. Conclusions: This will be the first randomized, double-blind, placebo-controlled clinical trial to assess the clinical efficacy of nesiritide in human ST-segment-elevation anterior AMI.