Acute Hemodynamic Comparison of Inhaled Nitric Oxide and Inhaled Epoprostenol in Pulmonary Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Change in mean pulmonary artery pressure
研究概览
简要总结
The overarching goal of this study is to examine the acute vasoreactive response to both inhaled nitric oxide and inhaled epoprostenol across both traditionally and non-traditionally interrogated phenotypes in PH, and to further characterize the relationship of vasoreactivity to disease severity and PH phenotype.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •mPAP ≥ 21mmHg, PAWP ≤ 25mmHg, and PVR ≥3 WU
- •Classified as WHO group I-III pulmonary hypertension
排除标准
- •WHO group IV and V pulmonary hypertension
- •Patients who are on baseline pulmonary vasodilator medications
- •Severe aortic or mitral valve disease
- •Patients who are pregnant
- •Left ventricular ejection fraction of <35%
- •Patients who are hospitalized as inpatients at the time of RHC
- •Patients with systolic blood pressure <90mmHg or mean arterial pressure of < 60mmHg
研究组 & 干预措施
Inhaled Nitric Oxide
Vasodilator testing will be performed with inhaled nitric oxide
干预措施: Vasodilator testing (Inhaled Nitric Oxide) (Drug)
Inhaled Epoprostenol
Vasodilator testing will be performed with inhaled epoprostenol
干预措施: Vasodilator testing (Inhaled Epoprostenol) (Drug)
结局指标
主要结局
Change in mean pulmonary artery pressure
时间窗: Pre-pulmonary vasodilator testing measurements (baseline) will be compared to post-pulmonary vasodilator testing measurements during diagnostic right heart catheterization.
The primary outcome will be change in mean pulmonary artery pressure (mmHg) from baseline to after 5-minutes of inhaled vasodilator.
次要结局
未报告次要终点
研究者
Aaron Waxman MD PhD
Associate Professor of Pulmonary and Critical Care
Brigham and Women's Hospital