Inhaled Iloprost for Sarcoidosis Associated Pulmonary Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in six minute walk distance
研究概览
简要总结
This trial will study the treatment of sarcoidosis-associated pulmonary arterial hypertension with inhaled iloprost, a drug approved for primary pulmonary arterial hypertension.
详细描述
Pulmonary hypertension has been described in sarcoidosis. It can be a significant problem, not responsive to treatment with anti-inflammatory drugs for the sarcoidosis (1;2). Inhaled iloprost has been approved for treatment of pulmonary hypertension (3). We propose to study the effectiveness of inhaled iloprost for sarcoidosis associated pulmonary hypertension (SAPAH). This is an open label trial, with patients receiving 16 weeks of therapy. Clinical and hemodynamic outcome of therapy will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with known sarcoidosis 17
- •Age 18 or greater
- •Patients with documented pulmonary hypertension with a PA mean > 25 mm as measured by cardiac catheterization within six months of entry into the study
- •Patients with dyspnea
- •Six minute walk distance of between 100 to 500 meters
- •Patients on stable immunotherapy for their sarcoidosis, including prednisone, methotrexate, azathioprine, hydroxychloroquine, cyclophosphamide, thalidomide, and/or infliximab
- •Patients able to provide written consent
排除标准
- •Patients on pulmonary vasodilator drugs (flolan, remodulin, bosentan, sildenafil) in the prior 28 days (patients on stable dose of calcium channel blocker for more than 1 month prior to right heart catheterization can be continued on the calcium channel blocker)
- •Patients with severe airway obstruction as defined by FEV1/FVC of less than 35%
- •Patients with World Health Organization (WHO) class IV status
- •Patients who are pregnant or breast feeding
- •Patients with significant left ventricular dysfunction with a left ventricular ejection fraction of less than 35%
- •Significant liver dysfunction not due to sarcoidosis
- •Patients with severe other organ disease felt by investigators to impact survival during the course of the study
- •Patients unable to perform the 6 inhalation treatments required for therapy
- •Patients with < 90 mm Hg Systolic systemic blood pressure will be excluded
研究组 & 干预措施
1
干预措施: Iloprost (Drug)
结局指标
主要结局
Change in six minute walk distance
时间窗: 24 weeks
次要结局
- Quality of life(24 weeks)
- Respiratory function(24 weeks)
- Toxicity(24 weeks)
- Pulmonary artery hemodynamics(24 weeks)
研究者
Robert P Baughman
Professor of Medicine
University of Cincinnati