Pulmonary Hypertension Secondary to Lung Disease and/or Hypoxia
Conditions
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.
Interventions
DRUGSildenafil
20 mg initially and then increased to 20 mg TDS if there is no fall in BP
DRUGBosentan
Bosentan 62.5 mg BD initially for 1 month and then increased to 125 mg BD
Sponsors
All India Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Echocardiogram | 6 months | Improvement in pulmonary artery pressures |
| WHO functional classification | 6 months | Improvement in WHO functional classification |
| 6 minute walk test | 6 months | Improvement in 6 minute walk test |
| Pulmonary function test | 6 months | Improvement in Pulmonary function test |
| Visual analog scale for dyspnea | 6 months | Improvement in Visual analog scale for dyspnea |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical markers at 3 and 6 months | 6 months | Levels of biomarkers such as Trop T, pro-BNP, uric acid at 3 months and 6 months after starting the drugs |
| Echocardiography measuring pulmonary artery pressure | 3 months | Improvement in pulmonary artery pressures measured by Echocardiography |
| Monitoring side effects of the drugs | 6 months | adverse events and serious adverse events will be closely monitored and reported to the ethics committee and DCGI immediately |
| WHO functional classification | 3 months | Improvement in WHO functional classification |
| 6 minute walk test | 3 months | Improvement in 6 minute walk test |
| Pulmonary function test | 3 months | Improvement in Pulmonary function test |
| Visual analog scale for dyspnea | 3 months | Improvement in Visual analog scale for dyspnea |
Countries
India
Contacts
Primary ContactSajal Ajmani, MBBS
Outcome results
None listed