A Phase II Randomized, Double Blind, Placebo-Controlled Study of Recombinant Human Relaxin in Patients With Decompensated Congestive Heart Failure
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Cardiac hemodynamics
研究概览
简要总结
Two doses of relaxin will be compared to placebo for the treatment of patients with decompensated CHF
详细描述
Pilot clinical data suggest that recombinant human relaxin may be effective in treating patients with decompensated CHF. This study will randomize patients in blinded manner to one of two doses of intravenous relaxin or placebo. Serial evaluations will include cardiac and renal function, as well as safety and tolerability.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalization
- •Decompensated chronic CHF (NYHA Class III-IV)
- •LVEF < 35%
- •PCWP > 22 mmHg
- •CI < 2.3 L/min/m2
排除标准
- •Acute CHF
- •Acute coronary syndrome
- •Hypotension or shock
- •Recent stroke
- •Allergy or sensitivity to test agents
- •Significant confounding conditions or medications
研究组 & 干预措施
Placebo
Participants receive diluent via continuous IV infusion for 48 hours.
干预措施: Placebo (Drug)
Low Dose rhRlx
Participants receive recombinant human relaxin (rhRlx) via continuous IV infusion for 48 hours at a rate of 100 µg/kg/day (corresponding to a dose of 4.2 µg/kg/hr).
干预措施: Recombinant human relaxin (rhRlx) (Drug)
High Dose rhRlx
Participants receive recombinant human relaxin (rhRlx) via continuous IV infusion for 48 hours at a rate of 500 µg/kg/day (corresponding to a dose of 21.0 µg/kg/hr).
干预措施: Recombinant human relaxin (rhRlx) (Drug)
结局指标
主要结局
Cardiac hemodynamics
时间窗: Baseline through 27 hours post-infusion or discharge from the hospital.
次要结局
- Renal function(Baseline through Day 10)
- Safety and Tolerability assessed by number of patients with adverse events (AEs)(Baseline through Day 30)