Combined Use of Angiography, Optical Coherence Tomography and Intravascular Ultrasound in Evaluation of Pulmonary Vascular Structure and Function in Patients With Pulmonary Arterial Hypertension Treated With Oral Bosentan
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in the measurement of Pulmonary arterial intimal + Medial thickening by OCT pre and post treatment with bosentan at 4 months
研究概览
简要总结
It has been hypothesized that one of the benefits of bosentan relates to pulmonary vascular remodeling. The investigators believe that this study will help document the nature of beneficial changes that occur in patients with Pulmonary Arterial Hypertension (PAH) in response to bosentan therapy. In turn, demonstrating that changes in pulmonary vascular structure and function accompany clinical improvement.
详细描述
Subjects will have Optical coherence tomography (OCT) and Intravascular Ultrasound (IVUS) imaging during the right heart catheterization that diagnoses them as having PAH. Subjects will start their bosentan and will be followed by monthly clinic visits for 4 months. At 4 months they will have repeat OCT and IVUS imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •WHO GROUP 1
- •Baseline 6-min walk distance (6MWD) between 200 and 450 m
- •Diagnosed with pulmonary artery hypertension during right heart catheterization (Mean Pulmonary Artery Pressure > 25mmHg)
- •General Exclusion Criteria
- •Pregnant or nursing
- •Acute or chronic illness other than those associated with PAH (collagen vascular disease, human immunodeficiency virus, or anorexigen use)
- •Previously received any investigational medications, prostanoids, or phosphodiesterase inhibitors
- •Failing right ventricle
排除标准
- 未提供
结局指标
主要结局
Change in the measurement of Pulmonary arterial intimal + Medial thickening by OCT pre and post treatment with bosentan at 4 months
时间窗: Baseline and 4 months
次要结局
- Change in pulmonary arterial pulsatility by IVUS pre and post treatment with bosentan at 4 months(Baseline and 4 months)
- Change in pulmonary arterial pressure/elastic strain index by IVUS pre and post treatment with bosentan at 4 months(Baseline and 4 months)
研究者
Ik-Kyung Jang, MD, PhD
Professor of Medicine
Massachusetts General Hospital