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

Sustained hemodynamic effects of an infusion of nesiritide (human b-type natriuretic peptide) in heart failure - A randomized, double-blind, placebo-controlled clinical trial
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DOI:
10.1016/s0735-1097(99)00184-9
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发表时间:
1999-07-01
影响因子:
24
通讯作者:
Chatterjee, K
Chatterjee, K
中科院分区:
医学1区
文献类型:
--
作者:
Mills, RM;LeJemtel, TH;Chatterjee, K

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本研究的目的是进一步确定奈西立肽的规则通过评估三种剂量的人B型利钠肽治疗失代偿性心力衰竭(HF)的血流动力学效应,(0.015、0.03和0.06 μ g/kg/min)通过连续静脉内(IV)输注给药24小时,与安慰剂相比。HF患者中推注剂量和6小时输注给药奈西立肽的神经激素和肾脏效应。长期的安全性和有效性nut已经study.METHODS这个随机,双盲,安慰剂对照的多中心试验招募有症状的HF和收缩功能障碍(左心室射血分数小于或等于35%)的主题。中心血流动力学进行了评估,在基线,在24小时静脉输液和4小时postinfus.Results 103例受试者与纽约心脏协会II级(6%),III(61%)或IV(33%)HF。奈西立肽可显著降低肺楔压(6 h降低27%-39%)、平均右心房压和体循环血管阻力,沿着心脏指数和每搏输出量指数显著增加,但对心率无显著影响。有益的效果是明显的,在1小时,并持续在整个24小时infusation.CONCLUSIONS快速和持续的有益的血流动力学效应,奈西立肽在这项研究中观察到支持其作为一线静脉治疗;患者有症状的失代偿性HF。(C)1999年由美国心脏病学会。
OBJECTIVES The goal of this studs was to further define the rule 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 mu g/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 nut been studied.METHODS This randomized, double-blind, placebo-controlled multicenter trial enrolled subjects with symptomatic HF and systolic dysfunction (left ventricular ejection fraction less than or equal to 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. (C) 1999 by the American College of Cardiology.