Comparison of Supplemental Oxygen and Nitric Oxide for Inhalation Plus Oxygen in the Evaluation of the Reactivity of the Pulmonary Vasculature During Acute Pulmonary Vasodilator Testing
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mallinckrodt
- 入组人数
- 136
- 试验地点
- 18
- 主要终点
- Number of Participants With Reversible Pulmonary Hypertension (Vasoreactivity)
研究概览
简要总结
The primary purpose of this study is to compare the number of participants with reversible pulmonary hypertension (vasoreactivity) due to nitric oxide for inhalation and oxygen as compared to 100% oxygen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 4 Weeks 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have any one of these three disease categories:
- •Idiopathic Pulmonary Arterial Hypertension
- •Mean pulmonary arterial pressure (PAPm) > 25 millimeters of mercury (mmHg) at rest, pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg, and PVRI> 3 u•m^2 or diagnosed clinically with no previous catheterization
- •Congenital heart disease (CHD) with pulmonary hypertension repaired and unrepaired
- •PAPm > 25 mmHg at rest and PVRI> 3 u•m^2 or diagnosed clinically with no previous catheterization
- •Cardiomyopathy
- •PAPm > 25 mmHg at rest and Pulmonary vascular resistance index (PVRI)> 3 u•m^2 or diagnosed clinically with no previous catheterization
- •Scheduled to undergo right heart catheterization to assess pulmonary vasoreactivity by acute pulmonary vasodilation testing.
- •Male or female, ages 4 weeks to 18 years, inclusive
- •Signed informed consent/assent
排除标准
- •Focal pulmonary infiltrates on chest radiograph.
- •Diagnosed with severe obstructive or restrictive pulmonary disease that is significantly contributing to the patient's pulmonary hypertension.
- •Received treatment with nitric oxide for inhalation within 30 days prior to study initiation, are on other investigational medications, nitroglycerin, sodium nitroprusside, sildenafil, other Phosphodiesterase type 5 (PDE-5) inhibitors, or prostacyclin
- •Pregnant [urine human chorionic gonadotropin positive (HCG +)]
- •Baseline Pulmonary capillary wedge pressure (PCWP) > 20 mmHg
研究组 & 干预措施
Nitric Oxide First, Oxygen Last
10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen on Day 1.
干预措施: Nitric Oxide for inhalation (Drug)
Nitric Oxide First, Oxygen Last
10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen on Day 1.
干预措施: Oxygen (Drug)
Nitric Oxide First, Oxygen Last
10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen on Day 1.
干预措施: Nitric Oxide plus Oxygen (Drug)
Oxygen First, Nitric Oxide Last
10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm on Day 1.
干预措施: Nitric Oxide for inhalation (Drug)
Oxygen First, Nitric Oxide Last
10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm on Day 1.
干预措施: Oxygen (Drug)
Oxygen First, Nitric Oxide Last
10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm on Day 1.
干预措施: Nitric Oxide plus Oxygen (Drug)
结局指标
主要结局
Number of Participants With Reversible Pulmonary Hypertension (Vasoreactivity)
时间窗: on Day 1
A composite of hemodynamic measurements were used to identify reversible pulmonary hypertension (vasoreactivity)
次要结局
- Number of Participants With Related Surgical Procedures Within 1 Year(within 1 year)
- Number of Participants With Adverse Events (AEs)(on Day 1)
- Number of Participants With Serious Adverse Events (SAEs)(within 12 hours)
- Number of Participants With Related Surgical Procedures Within 3 Years(within 3 years)