Placebo Controlled, Randomized, Double-blind, Multi-center, Multinational Phase IIb Study to Investigate the Efficacy and Tolerability of BAY58-2667 Given Intravenously in Patients With Decompensated Chronic Congestive Heart Failure
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 150
- 主要终点
- The primary efficacy outcome measure will be the change of pulmonary capillary wedge pressure (PCWP) from baseline to 8 hours versus placebo.
研究概览
简要总结
The purpose of this study is to assess a dose titration scheme, of a new drug (BAY58-2667) given intravenously, to evaluate if this is safe and can help to improve the well-being, symptoms (e.g. breathing) and outcome of decompensated heart failure. Patients living with chronic heart failure have a risk of increased number of hospitalisations because of worsening of their condition (decompensated heart failure). The current treatment of acute heart failure consists of oxygen and medical treatment with vasodilators and positive inotropic agents (drugs, which should strengthen the pump function of the heart) which have their limitations. Therefore there is a need for new drugs in treatment of acute heat failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients with decompensated chronic congestive heart failure, NYHA functional class III-IV, either ischemic or non-ischemic, requiring hospitalization, and with clinical indication for parenteral pharmacotherapy and invasive hemodynamic monitoring (i.e indwelling Swan-Ganz pulmonary artery catheter) and PCWP >/= 18 mmHg.
- •Patients must have the clinical diagnosis of CHF made at least 3 month prior to enrollment.
- •Male or female patients, age 18 years or more.
排除标准
- •Females of child-bearing potential.
- •Acute de-novo heart failure.
- •Acute myocardial infarction and/or myocardial infarction within 30 days.
- •Valvular heart disease requiring surgical intervention during the course of the study.
研究组 & 干预措施
Arm 1
干预措施: Placebo (Drug)
Arm 2
干预措施: Cinaciguat (BAY58-2667) (Drug)
结局指标
主要结局
The primary efficacy outcome measure will be the change of pulmonary capillary wedge pressure (PCWP) from baseline to 8 hours versus placebo.
时间窗: 8 hours
次要结局
- Quality of Life(Up to 30 days Follow-up)
- Other hemodynamic measurements(Up to 48 hours)
- Rehospitalization(Up to 30 days Follow-up)
- Safety variables(Up to 30 days follow up)
- Plasma concentrations(During both the titration and maintenance phases were evaluated.)