Effects of iNO on Invasively Derived Pulmonary Vascular Parameters in Patients With Pulmonary Arterial Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Difference in Ambulatory 6 Minute Walk Distance (6MWD) Pulmonary Artery (PA) Pressures (Systolic, Diastolic, Mean) Between the Post-intervention (iNO+) and Pre-intervention (iNO-) Condition as Measured by the CardioMems Device
研究概览
简要总结
Pulmonary hypertension is characterized by an increase in the pressures in the blood supply to the lungs greater than a mean pressure of 25mmHg and a concomitant increase in overall pulmonary vascular resistance (PVR). In patients who have remodeling of their pulmonary vasculature, PVR will increase with exercise instead of decreasing as it would in normal patients. Based on published evidence, the investigators intend to investigate the effects of inhaled nitric oxide (iNO) on patients undergoing standard exercise techniques who have separately and previously had an implanted pulmonary artery monitoring device (CardioMems by St Jude Medical, Inc.) placed.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females age 18 to 80 years with a diagnosis of pulmonary arterial hypertension (WHO Group I pulmonary hypertension).
- •Must be able to read and understand English and consent for themselves
- •Previously implanted CardioMems continuous PA pressure
- •Ambulatory and able to complete 6MWD test.
排除标准
- •Pregnant or lactating females; negative pregnancy test as confirmed by evaluation of data from pre-enrolled Risk Evaluation and Mitigation Strategies (REMS) program.
研究组 & 干预措施
Intervention
Determination of non-invasive pulmonary pressures by CardioMems device interrogation pre- and post-administration of inhaled nitric oxide at 0.075 mg/kg IBW/hr
干预措施: Nitric Oxide (Drug)
结局指标
主要结局
Difference in Ambulatory 6 Minute Walk Distance (6MWD) Pulmonary Artery (PA) Pressures (Systolic, Diastolic, Mean) Between the Post-intervention (iNO+) and Pre-intervention (iNO-) Condition as Measured by the CardioMems Device
时间窗: 2 hours
Difference between baseline (t=0) and post-intervention (t=2h)
次要结局
- Change in O2 Requirements(2 hours)
- Change in CardioMems Cardiac Output(2 hours)
- Change in 6 Minute Walk Distance (6MWD)(2 hours)
- Change in O2 Saturations(2 hours)
- Change in Modified Borg Dyspnea Scale(2 hours)
- Change in RV Stroke Work Index(2 hours)
- Change in Mean Arterial Pressure(2 hours)
- Change in Heart Rate(2 hours)
- Change in Stroke Volume(2 hours)
- Change in Rate Pressure Product(2 hours)
- Change in Right Ventricular (RV) Power(2 hours)
研究者
Raymond Benza
Physician
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)