comparison of efficacy Of different treatment regimens In pulmonary artery hypertension secondary to lung disease and/or hypoxia.
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Following parameters at 6 months
研究概览
简要总结
This is an open label, randomized, interventional study indented tofind the efficacy of different treatment regimens in treatment of pulmonaryhypertension secondary to lung disease and/or hypoxia. It involves 3 arms, onegetting monotherapy with sildenafil for 6 months, 2nd gettingbosentan monotherapy initially for 3 months and then combination of sildenafiland bosentan for 3 months, 3rd getting combination sildenafil andbosentan from the beginning for 6 months. The aim is to decide when is the besttime to start combination therapy either from start or at the time of drugfailure. Improvement will be assessed by change in functional class, pulmonarypressures measured by ECHO, pulmonary function test, six minute walk test andbiochemical markers. Lack of randomized trials and Indian data is there on thesubject. Also adverse events and serious adverse events will be closelymonitored and reported to the ethics committee and DCGI immediately.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Pulmonary artery hypertension diagnosed by doppler echocardiography as mean pulmonary artery pressure 25 mmHg (done in department of cardiology, AIIMS) •Age more than 18 years •Pulmonary artery hypertension due to hypoxia, either chronic obstructive airway disease or diffuse pulmonary lung disease •Willing to consent to participate in the trial •WHO functional class I,II, III.
排除标准
- •WHO functional class IV •Patient participating in any other trial •Concomitant coronary artery disease •Nitrate intake •Liver dysfunction •Pregnancy and lactation.
结局指标
主要结局
Following parameters at 6 months
时间窗: Following parameters at 6 months | •WHO functional classification | •6 minute walk test | •Pulmonary function test | •Visual analog scale for dyspnea | •Echocardiography measuring pulmonary artery pressure
•WHO functional classification
时间窗: Following parameters at 6 months | •WHO functional classification | •6 minute walk test | •Pulmonary function test | •Visual analog scale for dyspnea | •Echocardiography measuring pulmonary artery pressure
•6 minute walk test
时间窗: Following parameters at 6 months | •WHO functional classification | •6 minute walk test | •Pulmonary function test | •Visual analog scale for dyspnea | •Echocardiography measuring pulmonary artery pressure
•Pulmonary function test
时间窗: Following parameters at 6 months | •WHO functional classification | •6 minute walk test | •Pulmonary function test | •Visual analog scale for dyspnea | •Echocardiography measuring pulmonary artery pressure
•Visual analog scale for dyspnea
时间窗: Following parameters at 6 months | •WHO functional classification | •6 minute walk test | •Pulmonary function test | •Visual analog scale for dyspnea | •Echocardiography measuring pulmonary artery pressure
•Echocardiography measuring pulmonary artery pressure
时间窗: Following parameters at 6 months | •WHO functional classification | •6 minute walk test | •Pulmonary function test | •Visual analog scale for dyspnea | •Echocardiography measuring pulmonary artery pressure
次要结局
- Following parameters at 3 months(•WHO functional classification)