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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by All India Institute of Medical Sciences, New Delhi
Sponsor:
Information provided by (Responsible Party):
S.K.SHARMA, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT01449253
First received: October 7, 2011
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Pulmonary Hypertension Secondary to Lung Disease and/or Hypoxia
Drug: Sildenafil
Drug: Bosentan
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Efficacy Different Treatment Regimens in Pulmonary Hypertension Secondary to Lung Disease and or Hypoxia

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • Echocardiogram [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Improvement in pulmonary artery pressures

  • WHO functional classification [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Improvement in WHO functional classification

  • 6 minute walk test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Improvement in 6 minute walk test

  • Pulmonary function test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Improvement in Pulmonary function test

  • Visual analog scale for dyspnea [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Improvement in Visual analog scale for dyspnea


Secondary Outcome Measures:
  • Echocardiography measuring pulmonary artery pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Improvement in pulmonary artery pressures measured by Echocardiography

  • WHO functional classification [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Improvement in WHO functional classification

  • 6 minute walk test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Improvement in 6 minute walk test

  • Pulmonary function test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Improvement in Pulmonary function test

  • Visual analog scale for dyspnea [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Improvement in Visual analog scale for dyspnea

  • Biochemical markers at 3 and 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Levels of biomarkers such as Trop T, pro-BNP, uric acid at 3 months and 6 months after starting the drugs

  • Monitoring side effects of the drugs [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    adverse events and serious adverse events will be closely monitored and reported to the ethics committee and DCGI immediately


Estimated Enrollment: 60
Study Start Date: August 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Monotherapy
Sildenafil will be started at 20mg OD and then increased to 20mg TDS if there is no fall in BP. Total duration is of 6 months
Drug: Sildenafil
20 mg initially and then increased to 20 mg TDS if there is no fall in BP
Active Comparator: Sequential Therapy
Bosentan will be started at 62.5mg BD for 4 weeks and then increased to 125mg BD. Sildenafil will be started be added after 3 months. Sildenafil will be started at 20mg OD and then increased to 20mg TDS if there is no fall in BP. Total duration is of 6 months. Bosentan and sildenafil will be in combination in the last 3 months. No fixed dose combination will be used.
Drug: Sildenafil
20 mg initially and then increased to 20 mg TDS if there is no fall in BP
Drug: Bosentan
Bosentan 62.5 mg BD initially for 1 month and then increased to 125 mg BD
Active Comparator: Combination therapy
Bosentan will be started at 62.5mg BD for 4 weeks and then increased to 125mg BD. Sildenafil will be started at 20mg OD and then increased to 20mg TDS if there is no fall in BP. Total duration is of 6 months. No fixed dose combination will be used.
Drug: Sildenafil
20 mg initially and then increased to 20 mg TDS if there is no fall in BP
Drug: Bosentan
Bosentan 62.5 mg BD initially for 1 month and then increased to 125 mg BD

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449253

Contacts
Contact: Sajal Ajmani, MBBS 919873570408 sajalajmani@gmail.com

Locations
India
All India Institute Of Medical Sciences Recruiting
New Delhi, Delhi, India, 110029
Contact: Sajal Ajmani, MBBS    9873570408    sajalajmani@gmail.com   
Principal Investigator: Surendra K Sharma, MD, Ph D         
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Principal Investigator: Surendra K. Sharma, MD,Ph.D All India Institute of Medical Sciences, New Delhi
  More Information

No publications provided

Responsible Party: S.K.SHARMA, HOD Medicine, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT01449253     History of Changes
Other Study ID Numbers: pulmonary hypertension
Study First Received: October 7, 2011
Last Updated: January 28, 2013
Health Authority: India: Drugs Controller General of India
India: Indian Council of Medical Research

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Lung Diseases
Anoxia
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Bosentan
Sildenafil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014