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

This study was presented in part at the 45th Annual Scientific Session of the American College of Cardiology, 1997.
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Abstract

OBJECTIVES

The goal of this study was to further define the role of nesiritide (human b-type natriuretic peptide) in the therapy of decompensated heart failure (HF) by assessing the hemodynamic effects of three doses (0.015, 0.03 and 0.06 μg/kg/min) administered by continuous intravenous (IV) infusion over 24 h as compared with placebo.

BACKGROUND

Previous studies have shown beneficial hemodynamic, neurohormonal and renal effects of bolus dose and 6-h infusion administration of nesiritide in HF patients. Longer term safety and efficacy have not been studied.

METHODS

This randomized, double-blind, placebo-controlled multicenter trial enrolled subjects with symptomatic HF and systolic dysfunction (left ventricular ejection fraction ≤35%). Central hemodynamics were assessed at baseline, during a 24-h IV infusion and for 4 h postinfusion.

RESULTS

One hundred three subjects with New York Heart Association class II (6%), III (61%) or IV (33%) HF were enrolled. Nesiritide produced significant reductions in pulmonary wedge pressure (27% to 39% decrease by 6 h), mean right atrial pressure and systemic vascular resistance, along with significant increases in cardiac index and stroke volume index, with no significant effect on heart rate. Beneficial effects were evident at 1 h and were sustained throughout the 24-h infusion.

CONCLUSIONS

The rapid and sustained beneficial hemodynamic effects of nesiritide observed in this study support its use as a first-line IV therapy for patients with symptomatic decompensated HF.

Abbreviations

CI
cardiac index
hBNP
human b-type natriuretic peptide
HF
heart failure
IV
intravenous
MRAP
mean right atrial pressure
PCWP
pulmonary capillary wedge pressure
SBP
systemic systolic blood pressure
SVR
systemic vascular resistance

Cited by (0)

This study was supported by a grant from Scios Inc., Mountain View, California.

1

The investigators of the Natrecor Study Group and their affiliated institutions are listed under Acknowledgments.