NCT00699712已完成2 期
Multi-Center, Open Label, Dose Escalating, Sequential Group Study to Assess the Hemodynamic Effects, Safety and Tolerability of CD-NP in Patients With Stabilized Acute Heart Failure (AHF)
Nile Therapeutics1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in cardiac output and wedge pressure
研究概览
简要总结
To access the efficacy of intravenous (IV) administration of CD-NP on changes in cardiac output and wedge pressure in patients with stabilized acute heart failure
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalization for AHF
- •In need of hemodynamic monitoring
排除标准
- •Administration of intravenous radiographic contrast agent within 7 days prior to screening or planned IV contrast media administration in the 4 days after screening or acute contrast-induced nephropathy at the time of screening
- •Current or planned treatment with any IV therapies, including diuretics, vasodilators (including nesiritide), vasopressin antagonists, positive inotropic agents and vasopressors, or mechanical support
- •Current or planned ultrafiltration, hemofiltration, or dialysis within 7 days of screening
- •Significant pulmonary disease
- •Known valvular heart disease
- •Any organ transplant recipient or patient currently listed for transplant or admitted for any transplantation.
- •Major surgery within 30 days of screening
- •Other major disability or disease with expected survival less than 6 months.
- •Major neurologic event, including cerebrovascular events, in the 60 days prior to screening
- •Clinical diagnosis of acute coronary syndrome within 45 days of screening
- •Troponin T ≥ 3 times the upper limit of normal at screening
- •Significant arrhythmias
- •Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy
- •Liver function abnormality
- •Administration of an investigational drug or implantation of investigational device, or participation in another trial, within 30 days prior to screening
研究组 & 干预措施
A
Experimental
Open-label regimen of doses 1 and 2 of CDNP
干预措施: CD-NP (Chimeric natriuretic peptide) (Drug)
B
Experimental
Open-label regimen of doses 2 and 3 of CDNP
干预措施: CD-NP (Chimeric natriuretic peptide) (Drug)
C
Experimental
Open-label regimen of doses 3 and 4 of CDNP
干预措施: CD-NP (Chimeric natriuretic peptide) (Drug)
结局指标
主要结局
Changes in cardiac output and wedge pressure
时间窗: 8 hours
次要结局
- Safety of CD-NP(30 Days)
- Changes in additional hemodynamic measures(8 hours)
- Diuresis and natriuresis during and after administration of study drug(36 hour)
研究者
研究点 (1)
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