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临床试验/NCT01837849
NCT01837849已完成不适用

Comparative Effects of Recombinant Human Brain Natriuretic Peptide and Dobutamine on Acute Decompensated Heart Failure Patients With Different Blood BNP Levels

Nantong University0 个研究点目标入组 104 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
104
主要终点
left ventricular ejection fraction (LVEF) in the High and Extra-high BNP Groups

研究概览

简要总结

To compare the therapeutic efficacy of recombinant human brain natriuretic peptide (rhBNP) with dobutamine on acute decompensated heart failure patients with different blood BNP levels

详细描述

Patients with acute decompensated heart failure (ADHF) whose left ventricular ejection fraction(LVEF) was <40%, were assigned to a high BNP group (BNP ≤ 3000 pg/mL) or an extra-high BNP group (BNP > 3000 pg/mL) , depending on their admission plasma BNP levels. Each group was then subdivided into rhBNP or dobutamine subgroups according to intravenous administration with either rhBNP or dobutamine for 24-72h. The effects of rhBNP and dobutamine on patients in the high and extra-high BNP groups were compared.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients were classified as NYHA class III-IV
  • ejection fraction <40%

排除标准

  • intravenous administration with rhBNP or dobutamine in the 2 weeks before study entry
  • acute myocardial infarction
  • significant valvular stenosis
  • serious ventricular arrhythmia (frequent ventricular premature beat of >5 bpm, nonsustained and sustained ventricular tachycardia)
  • blood pressure <95/60 mmHg or >140/90 mmHg
  • hypovolemia
  • hepatic or renal impairment
  • pregnant and lactating women.

结局指标

主要结局

left ventricular ejection fraction (LVEF) in the High and Extra-high BNP Groups

时间窗: baseline and 5 days

Left ventricle end diastolic dimension (LVEDD)in the High and Extra-high BNP Groups

时间窗: baseline and 5 days

Blood BNP in the High and Extra-high BNP Groups

时间窗: baseline and 5 days

次要结局

  • Blood Pressure (mmHg)(baseline and 5 days)
  • Heart Rate(baseline and 5 days)
  • Changes in New York Heart Association (NYHA) Class from Baseline to Day 5 after Treatment(baseline and 5 days)
  • Plasma Creatinine(baseline and 5 days)

研究者

发起方
Nantong University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Haiyan PAN

associate chief physician

Nantong University

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