Clinical trial NCT01449253: Comparison of Efficacy Different Treatment Regimens in Pulmonary Hypertension Secondary to Lung Disease and or Hypoxia
Official title: Comparison of Efficacy Different Treatment Regimens in Pulmonary Hypertension Secondary to Lung Disease and or Hypoxia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pulmonary Hypertension Secondary to Lung Disease and/or Hypoxia
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2011-10-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 -

Primary outcomes:
measure: Echocardiogram
timeFrame: 6 months
measure: WHO functional classification
timeFrame: 6 months
measure: 6 minute walk test
timeFrame: 6 months
measure: Pulmonary function test
timeFrame: 6 months
measure: Visual analog scale for dyspnea
timeFrame: 6 months
Secondary outcomes:
measure: Echocardiography measuring pulmonary artery pressure
timeFrame: 3 months
measure: WHO functional classification
timeFrame: 3 months
measure: 6 minute walk test
timeFrame: 3 months
measure: Pulmonary function test
timeFrame: 3 months
measure: Visual analog scale for dyspnea
timeFrame: 3 months
measure: Biochemical markers at 3 and 6 months
timeFrame: 6 months
measure: Monitoring side effects of the drugs
timeFrame: 6 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: All India Institute Of Medical Sciences
state: Delhi
Study officials:
affiliation: All India Institute of Medical Sciences
name: Surendra K. Sharma, MD,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: