Comparison of Efficacy Different Treatment Regimens in Pulmonary Hypertension Secondary to Lung Disease and or Hypoxia
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Echocardiogram
研究概览
简要总结
This is an open label, randomized, interventional study indented to find the efficacy of different treatment regimens in treatment of pulmonary hypertension secondary to lung disease and/or hypoxia.This is to find out when to start combination therapy (sildenafil plus bosentan) in treatment of pulmonary hypertension secondary to lung disease and/or hypoxia.
详细描述
This is an open label, randomized, interventional study indented to find the efficacy of different treatment regimens in treatment of pulmonary hypertension secondary to lung disease and/or hypoxia. It involves 3 arms, one getting monotherapy with sildenafil for 6 months, 2nd getting bosentan monotherapy initially for 3 months and then combination of sildenafil and bosentan for 3 months, 3rd getting combination sildenafil and bosentan from the beginning for 6 months. The aim is to decide when is the best time to start combination therapy either from start or at the time of drug failure. Improvement will be assessed by change in functional class, pulmonary pressures measured by ECHO, pulmonary function test, six minute walk test and biochemical markers. Lack of randomized trials and Indian data is there on the subject. Also adverse events and serious adverse events will be closely monitored and reported to the ethics committee and DCGI immediately.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 -
研究组 & 干预措施
Monotherapy
Sildenafil will be started at 20mg OD and then increased to 20mg TDS if there is no fall in BP. Total duration is of 6 months
干预措施: Sildenafil (Drug)
Sequential Therapy
Bosentan will be started at 62.5mg BD for 4 weeks and then increased to 125mg BD. Sildenafil will be started be added after 3 months. Sildenafil will be started at 20mg OD and then increased to 20mg TDS if there is no fall in BP. Total duration is of 6 months. Bosentan and sildenafil will be in combination in the last 3 months. No fixed dose combination will be used.
干预措施: Sildenafil (Drug)
Sequential Therapy
Bosentan will be started at 62.5mg BD for 4 weeks and then increased to 125mg BD. Sildenafil will be started be added after 3 months. Sildenafil will be started at 20mg OD and then increased to 20mg TDS if there is no fall in BP. Total duration is of 6 months. Bosentan and sildenafil will be in combination in the last 3 months. No fixed dose combination will be used.
干预措施: Bosentan (Drug)
Combination therapy
Bosentan will be started at 62.5mg BD for 4 weeks and then increased to 125mg BD. Sildenafil will be started at 20mg OD and then increased to 20mg TDS if there is no fall in BP. Total duration is of 6 months. No fixed dose combination will be used.
干预措施: Sildenafil (Drug)
Combination therapy
Bosentan will be started at 62.5mg BD for 4 weeks and then increased to 125mg BD. Sildenafil will be started at 20mg OD and then increased to 20mg TDS if there is no fall in BP. Total duration is of 6 months. No fixed dose combination will be used.
干预措施: Bosentan (Drug)
结局指标
主要结局
Echocardiogram
时间窗: 6 months
Improvement in pulmonary artery pressures
WHO functional classification
时间窗: 6 months
Improvement in WHO functional classification
6 minute walk test
时间窗: 6 months
Improvement in 6 minute walk test
Pulmonary function test
时间窗: 6 months
Improvement in Pulmonary function test
Visual analog scale for dyspnea
时间窗: 6 months
Improvement in Visual analog scale for dyspnea
次要结局
- Biochemical markers at 3 and 6 months(6 months)
- Echocardiography measuring pulmonary artery pressure(3 months)
- WHO functional classification(3 months)
- 6 minute walk test(3 months)
- Pulmonary function test(3 months)
- Visual analog scale for dyspnea(3 months)
- Monitoring side effects of the drugs(6 months)
研究者
S.K.SHARMA
HOD Medicine
All India Institute of Medical Sciences, New Delhi