Comparison of Efficacy Different Treatment Regimens in Pulmonary Hypertension Secondary to Lung Disease and or Hypoxia
Overview
- Phase
- Phase 4
- Intervention
- Sildenafil
- Conditions
- Pulmonary Hypertension Secondary to Lung Disease and/or Hypoxia
- Sponsor
- All India Institute of Medical Sciences, New Delhi
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Echocardiogram
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
S.K.SHARMA
HOD Medicine
All India Institute of Medical Sciences, New Delhi
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •WHO functional class IV
- •Patient participating in any other trial
- •Concomitant coronary artery disease
- •Nitrate intake
- •Liver dysfunction
- •Pregnancy and lactation -
Arms & Interventions
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
Intervention: Sildenafil
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.
Intervention: Sildenafil
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.
Intervention: Bosentan
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.
Intervention: Sildenafil
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.
Intervention: Bosentan
Outcomes
Primary Outcomes
Echocardiogram
Time Frame: 6 months
Improvement in pulmonary artery pressures
WHO functional classification
Time Frame: 6 months
Improvement in WHO functional classification
6 minute walk test
Time Frame: 6 months
Improvement in 6 minute walk test
Pulmonary function test
Time Frame: 6 months
Improvement in Pulmonary function test
Visual analog scale for dyspnea
Time Frame: 6 months
Improvement in Visual analog scale for dyspnea
Secondary Outcomes
- 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)