Comparison Of Efficacy Of Different Treatment Regimens In Pulmonary Artery Hypertension Secondary To Lung Disease And/Or Hypoxia

Phase 3

Recruiting

• Conditions: Pulmonary artery hypertension secondary to lung disease and/or hypoxia

• Registration Number: CTRI/2011/09/001992
• Lead Sponsor: Dr SK Sharma

Brief Summary

This is an open label, randomized, interventional study indented tofind the efficacy of different treatment regimens in treatment of pulmonaryhypertension secondary to lung disease and/or hypoxia. It involves 3 arms, onegetting monotherapy with sildenafil for 6 months, 2nd gettingbosentan monotherapy initially for 3 months and then combination of sildenafiland bosentan for 3 months, 3rd getting combination sildenafil andbosentan from the beginning for 6 months. The aim is to decide when is the besttime to start combination therapy either from start or at the time of drugfailure. Improvement will be assessed by change in functional class, pulmonarypressures measured by ECHO, pulmonary function test, six minute walk test andbiochemical markers. Lack of randomized trials and Indian data is there on thesubject. Also adverse events and serious adverse events will be closelymonitored and reported to the ethics committee and DCGI immediately.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-09
• Last Update Posted: 2011-07-09

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Following parameters at 6 months	Following parameters at 6 months | •WHO functional classification | •6 minute walk test | •Pulmonary function test | •Visual analog scale for dyspnea | •Echocardiography measuring pulmonary artery pressure
•WHO functional classification	Following parameters at 6 months | •WHO functional classification | •6 minute walk test | •Pulmonary function test | •Visual analog scale for dyspnea | •Echocardiography measuring pulmonary artery pressure
•6 minute walk test	Following parameters at 6 months | •WHO functional classification | •6 minute walk test | •Pulmonary function test | •Visual analog scale for dyspnea | •Echocardiography measuring pulmonary artery pressure
•Pulmonary function test	Following parameters at 6 months | •WHO functional classification | •6 minute walk test | •Pulmonary function test | •Visual analog scale for dyspnea | •Echocardiography measuring pulmonary artery pressure
•Visual analog scale for dyspnea	Following parameters at 6 months | •WHO functional classification | •6 minute walk test | •Pulmonary function test | •Visual analog scale for dyspnea | •Echocardiography measuring pulmonary artery pressure
•Echocardiography measuring pulmonary artery pressure	Following parameters at 6 months | •WHO functional classification | •6 minute walk test | •Pulmonary function test | •Visual analog scale for dyspnea | •Echocardiography measuring pulmonary artery pressure

Secondary Outcome Measures

Name	Time	Method
Following parameters at 3 months	•WHO functional classification

Trial Locations

Locations (2)

AIIMS hospital; 🇮🇳 South, DELHI, India

Medicine OPD all rooms; 🇮🇳 South, DELHI, India

AIIMS hospital

🇮🇳South, DELHI, India

Dr Sajal Ajmani

Principal investigator

9873570408

sajalajmani@gmail.com