Comparison of Efficacy Different Treatment Regimens in Pulmonary Hypertension Secondary to Lung Disease and or Hypoxia
Comparison of Efficacy Different Treatment Regimens in Pulmonary Hypertension Secondary to Lung Disease and or Hypoxia
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.
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.
Inclusion Criteria:

 1. Pulmonary artery hypertension diagnosed by doppler echocardiography as mean pulmonary
 artery pressure 25 mmHg (done in department of cardiology, AIIMS)

 2. Age more than 18 years

 3. Pulmonary artery hypertension due to hypoxia, either chronic obstructive airway
 disease or diffuse pulmonary lung disease

 4. Willing to consent to participate in the trial

 5. WHO functional class I,II, III

 Exclusion Criteria:

 1. WHO functional class IV

 2. Patient participating in any other trial

 3. Concomitant coronary artery disease

 4. Nitrate intake

 5. Liver dysfunction

 6. Pregnancy and lactation -