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J Am Coll Cardiol, 1999; 34:155-162
© 1999 by the American College of Cardiology Foundation
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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

Roger M. Mills, MD, FACC*, Thierry H. LeJemtel, MD{dagger}, Darlene P. Horton, MD{ddagger}, Chang-seng Liang, MD, PhD, FACC§, Roberto Lang, MD, FACC||, Marc A. Silver, MD, FACC, Charles Lui, MD, FACC#, Kanu Chatterjee, MD, FACC** on Behalf of the Natrecor Study Group1

* Division of Cardiovascular Medicine, University of Florida, Gainesville, Florida, USA
{dagger} Division of Cardiology, Albert Einstein College of Medicine, Bronx, New York, USA
{ddagger} Clinical Research Division, Scios Inc., Mountain View, California, USA
§ Cardiology Unit, University of Rochester Medical Center, Rochester, New York, USA
|| Section of Cardiology, University of Chicago, Chicago, Illinois, USA
Division of Cardiology, Loyola University Medical Center, Maywood, Illinois, USA
# Division of Cardiology, University of Arizona, Tucson, Arizona, USA
** Division of Cardiology, University of California San Francisco, San Francisco, California, USA

Manuscript received September 30, 1998; revised manuscript received February 24, 1999, accepted March 31, 1999.

Reprint requests and correspondence: Dr. Roger M. Mills, Desk F-15, Department of Cardiology, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, Ohio 44195

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 and Acronyms
  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




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