The Role of Endothelin in Pulmonary Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Pulmonary Vascular Resistance (PVR)
研究概览
简要总结
The purpose of the study is is to determine the effect, on the lung circulation, of BQ-123, an investigational compound which is not approved by the FDA.
详细描述
Endothelin levels are increased in patients with pulmonary hypertension. We wish to compare the effect of an endothelin antagonist on pulmonary hypertension due to a variety of causes.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers or known diagnosis of pulmonary hypertension
排除标准
- •hypertension due to other reasons (not pulmonary)
研究组 & 干预措施
1
BQ-123
干预措施: BQ-123 (Drug)
结局指标
主要结局
Pulmonary Vascular Resistance (PVR)
时间窗: Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)
PVR will be measured at these 5 time points: 1) Baseline, 2) Hypoxia induced and maintained for 15 min post-baseline at which time the measurement is taken again, 3) Baseline oxygen saturation (Normoxia) reestablished 15 min post-hypoxia period, at which time the measurement is taken again 4) Normoxia measurement taken after BQ-123 administered for 60 min after time point 3, 5) Hypoxia induced and maintained for 15 min after BQ-123 normoxia period, at which time the measurement is taken again.
次要结局
- Systemic Vascular Resistance (SVR)(Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description))
- Cardiac Output (CO)(Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description))
- Mean Pulmonary Artery Pressure (PAP)(Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description))
研究者
Anju Nohria
Principal Investigator
Brigham and Women's Hospital