NCT00851929已完成2 期
Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in 6 minute walk distance.
研究概览
简要总结
Hypothesis: Ambrisentan (Letairis ®) is safe and effective in treating pulmonary hypertension in patients with Sarcoidosis
详细描述
Primary Endpoint: Change in 6 minute walk distance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven sarcoidosis
- •Mean pulmonary artery pressure > 25 mmHg at rest and greater than 30 mmHg with exercise by right heart catheterization within 1 year prior to entry into study
- •Pulmonary capillary wedge pressure ≤ 15 mmHg
- •PVR values >3.0 Woods units
- •Forced vital capacity (FVC) >40%
- •WHO functional class II or III
- •Stable sarcoidosis treatment regimen for three months prior to entry into study
- •6 minute walk distance between 150-450 meters
- •Stable dose of antihypertensive medications
- •On no other medication to treat PAH (sildenafil, tadalafil, vardenafil, treprostinil, epoprostenol, iloprost, bosentan, sitaxsentan) within one month prior to enrollment and during duration of the study
- •Non-pregnant females
排除标准
- •Exercise limitation related to a non-cardiopulmonary reason (e.g. arthritis)
- •Severe systemic hypertension > 170/95
- •Patients with congestive heart failure (left ventricular dysfunction) or primary right ventricular dysfunction
- •Anticipation by the investigator for escalation in sarcoidosis treatment during the course of the study
- •Pulmonary hypertension related to etiology other than sarcoidosis (i.e. HIV, scleroderma, etc.)
- •Use within 1 month of an endothelin receptor antagonists (bosentan, sitaxsentan).
- •WHO functional class IV status
- •Patients with significant left ventricular dysfunction
- •Significant liver dysfunction not due to sarcoidosis.
- •Patients with severe other organ disease felt by investigators to impact on survival during the course of the study.
研究组 & 干预措施
sarcoidosis associated pulmonary hypertension
Experimental
sarcoidosis associated pulmonary hypertension
干预措施: Ambrisentan (Drug)
结局指标
主要结局
Change in 6 minute walk distance.
时间窗: 4 months of therapy
次要结局
未报告次要终点
研究者
研究点 (2)
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