Randomized Placebo-Controlled Study of Sildenafil For The Treatment of Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis: A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- 6 minute walk distance (6MWD) change from Baseline
研究概览
简要总结
Pulmonary Arterial Hypertension (PAH) in the setting of Idiopathic Pulmonary Fibrosis(IPF)is a risk factor for morbidity and mortality in the peri-lung transplant(LT) setting. Currently there is no significant data to support the use of pulmonary vasodilators for PAH in the setting of interstitial lung disease such as IPF. The majority of IPF patients have PAH either at rest or during exercise. The study hypothesis is that sildenafil may improve morbidity and mortality in the peri-LT setting in both IPF cohorts with either resting or exercise PAH.
详细描述
The purpose of this study is to evaluate the use of sildenafil in patients with pulmonary fibrosis and PH being considered for lung transplantation. We hypothesize that not only will sildenafil improve functionality and QOL in the pre-transplant setting but it may also improve primary graft dysfunction after lung transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Idiopathic Pulmonary Fibrosis referred for lung transplantation at our medical center
- •Minimal 6 minute walk distance of 50 meters; must be able to conduct supine exercise during heart catheterization
排除标准
- •Non ambulatory
- •Prior adverse reaction/allergy to sildenafil or other PDE-5 Inhibitors
- •Any other pulmonary vasodilator within one month of enrollment
研究组 & 干预措施
Pre-transplant placebo
There are two placebo comparators.... one for the group of patients with resting PAH and another for the group of patients with exercise PAH
干预措施: sildenafil (Drug)
Pre-transplant sildenafil
There are two active comparators, one group with resting PAH and another with exercise PAH, both receiving drug.
干预措施: sildenafil (Drug)
结局指标
主要结局
6 minute walk distance (6MWD) change from Baseline
时间窗: 6 months
ATS guideline based 6MW distance
次要结局
- Right heart catheterization hemodynamics(initial right heart catheterization compared to catheterization done on day of lung transplantation; we will specifically compare mean pulmonary artery pressure, pulmonary vascular resistance, and pulmonary artery wedge pressure)
- Quality of life assessment(study entry compared to 6 months or at the time of lung transplantation (whichever comes first); there is a 0-100 scoring scale and the lower the score, the more disability)
- Quality of life assessment in the context of dyspnea(the SGRQ will be be compared at two time points, study entry and at 6 months or the time of transplantation (whichever comes first); scores range from 0 to 100 and higher scores indicate more limitation)
- Chemokine analysis on peripheral blood(the chemokines will be quantified and compared between study entry and the time point just prior to lung transplantation)