Effect of Inhaled Albuterol on Pulmonary Hemodynamics in Patients With Group 1 Pulmonary Arterial Hypertension on Oral Pulmonary Vasodilator Therapy: A Proof of Concept Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Mean Pulmonary Artery Pressure (MPAP)
研究概览
简要总结
The purpose of the present pilot study is to test the hypothesis that in patients with group 1 pulmonary arterial hypertension (PAH) who are on regular oral pulmonary vasodilator therapy, inhaled albuterol causes transient pulmonary vasodilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •A Mean Pulmonary Artery Pressure >25mmHg, Pulmonary Vascular Resistance >3 wood/units and pulmonary arterial wedge pressure <15mmHg, as documented by right heart catheterization within the last 3 years
- •Regular use of oral pulmonary vasodilators
排除标准
- •Presence of chronic respiratory disease (as documented by prior lung imaging and pulmonary function tests), cardiovascular disease (as documented by prior echocardiography and/or left heart catheterization), thromboembolic PAH (as documented by pulmonary angiography)
- •women of childbearing potential who do not use accepted birth- control measures
- •pregnant and breast-feeding women
- •respiratory infection within 4 weeks of testing
- •A systemic systolic arterial BP> 150 and/or diastolic arterial BP>100 on the experiment day
- •A resting O2 saturation of < 90%
- •Current smoking
- •BMI >35 kg/m2 and/or a diagnosis of obstructive sleep apnea
- •Use of inhaled or intravenous pulmonary vasodilators
研究组 & 干预措施
Albuterol followed by placebo
Participants in this group will receive albuterol first followed by Placebo on the next visit
干预措施: Albuterol (Drug)
Albuterol followed by placebo
Participants in this group will receive albuterol first followed by Placebo on the next visit
干预措施: Placebo (Drug)
Placebo followed by albuterol
Participants in this group will receive placebo first followed by albuterol on the next visit
干预措施: Albuterol (Drug)
Placebo followed by albuterol
Participants in this group will receive placebo first followed by albuterol on the next visit
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Mean Pulmonary Artery Pressure (MPAP)
时间窗: Baseline, up to 30 minutes after inhalation
Change in MPAP will be measured using echocardiogram
次要结局
- Change in Pulmonary Vascular Resistance (PVR)(Baseline, up to 30 minutes after inhalation)
研究者
Adam Wanner
Professor of Medicine
University of Miami