Sustained hemodynamic effects of an infusion of nesiritide (human b-type natriuretic peptide) in heart failure - A randomized, double-blind, placebo-controlled clinical trial

OBJECTIVES The goal of this studs was to further define the rule of nesirit ide (human b-type natriuretic peptide) in the therapy of decompensated hear t failure (HF) by assessing the hemodynamic effects of three doses (0.015, 0.03 and 0.06 mu g/kg/min) administered by continuous intravenous (IV) infu sion over 24 h as compared with placebo. BACKGROUND Previous studies have shown beneficial hemodynamic, neurohormona l and renal effects of bolus dose and 6-h infusion administration of nesiri tide in HF patients. Longer term safety and efficacy have nut been studied. METHODS This randomized, double-blind, placebo-controlled multicenter trial enrolled subjects with symptomatic HF and systolic dysfunction (left ventr icular ejection fraction less than or equal to 35%). Central hemodynamics w ere assessed at baseline, during a 24-h IV infusion and for 4 h postinfusio n. RESULTS One hundred three subjects with New York Heart Association class II (6%), III (61%) or IV (33%) HF were enrolled. Nesiritide produced signific ant reductions in pulmonary wedge pressure (27% to 39% decrease by 6 h), me an right atrial pressure and systemic vascular resistance, along with signi ficant increases in cardiac index and stroke volume index, with no signific ant effect on heart rate. Beneficial effects were evident at 1 h and were s ustained throughout the 24-h infusion. CONCLUSIONS The rapid and sustained beneficial hemodynamic effects of nesir itide observed in this study support its use as a first-line IV therapy for ; patients with symptomatic decompensated HF. (C) 1999 by the American Coll ege of Cardiology.