NCT00259116已完成2 期
A Pilot Safety and Dose-Finding Trial of Intravenous Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2005年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Cardiac hemodynamics including PCWP, CO/CI, SVR
研究概览
简要总结
This trial is a single center, open-label, dose-finding study of recombinant human relaxin (rhRlx) given intravenously (IV) to patients with stable, compensated CHF.
详细描述
Serial cohorts of patients with stable CHF will be enrolled upon meeting eligibility criteria. Dose escalation will be guided by hemodynamic response, safety and tolerability. The effects of rhRlx on hemodynamics will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients over the age of 18
- •New York Heart Association (NYHA) Class II-III CHF
- •Left Ventricular Ejection Fraction (LVEF) of < 35%
排除标准
- •Acute coronary syndrome
- •Acute decompensated CHF
- •Hypotension
- •Recent significant arrhythmia
- •Recent stroke
- •Significant renal or hepatic impairment
- •Pregnancy or child-bearing potential
结局指标
主要结局
Cardiac hemodynamics including PCWP, CO/CI, SVR
次要结局
- Tolerability
- Safety and tolerability
研究者
研究点 (2)
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