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

Pulmonary Hypertension Secondary to Lung Disease and/or Hypoxia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01449253
• Other study ID #: pulmonary hypertension
• Status: Recruiting
• Phase: Phase 4
• First received: October 7, 2011
• Last updated: January 28, 2013
• Start date: August 2011
• Est. completion date: July 2013

Study information

• Verified date: January 2013
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: Sajal Ajmani, MBBS
• Phone: 919873570408
• Email: sajalajmani[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of IndiaIndia: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 -

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Lung Diseases
• Neoplasm Metastasis
• Pulmonary Hypertension Secondary to Lung Disease and/or Hypoxia

Intervention

Drug:
• Sildenafil
20 mg initially and then increased to 20 mg TDS if there is no fall in BP
• Bosentan
Bosentan 62.5 mg BD initially for 1 month and then increased to 125 mg BD

Locations

Country	Name	City	State
India	All India Institute Of Medical Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Echocardiogram	Improvement in pulmonary artery pressures	6 months	No
Primary	WHO functional classification	Improvement in WHO functional classification	6 months	No
Primary	6 minute walk test	Improvement in 6 minute walk test	6 months	No
Primary	Pulmonary function test	Improvement in Pulmonary function test	6 months	No
Primary	Visual analog scale for dyspnea	Improvement in Visual analog scale for dyspnea	6 months	No
Secondary	Echocardiography measuring pulmonary artery pressure	Improvement in pulmonary artery pressures measured by Echocardiography	3 months	No
Secondary	WHO functional classification	Improvement in WHO functional classification	3 months	No
Secondary	6 minute walk test	Improvement in 6 minute walk test	3 months	No
Secondary	Pulmonary function test	Improvement in Pulmonary function test	3 months	No
Secondary	Visual analog scale for dyspnea	Improvement in Visual analog scale for dyspnea	3 months	No
Secondary	Biochemical markers at 3 and 6 months	Levels of biomarkers such as Trop T, pro-BNP, uric acid at 3 months and 6 months after starting the drugs	6 months	No
Secondary	Monitoring side effects of the drugs	adverse events and serious adverse events will be closely monitored and reported to the ethics committee and DCGI immediately	6 months	Yes