Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With Bosentan

Phase 4

Withdrawn

• Conditions: Pulmonary Arterial Hypertension; Idiopathic Pulmonary Fibrosis
• Interventions: Drug: bosentan

• Registration Number: NCT00625469
• Lead Sponsor: Rajan Saggar

Brief Summary

Pulmonary Arterial Hypertension (PAH) in the setting of Idiopathic Pulmonary Fibrosis(IPF)is a risk factor for morbidity and mortality in the peri-lung transplant(LT) setting. Currently there is no significant data to support the use of pulmonary vasodilators for PAH in the setting of interstitial lung disease such as IPF. The majority of IPF patients have PAH either at rest or during exercise. The study hypothesis is that bosentan may improve morbidity and mortality in the peri-LT setting in both IPF cohorts with either resting or exercise PAH.

Detailed Description

The purpose of this study was to evaluate bosentan in the setting of exercise or resting pulmonary hypertension in patients with underlying pulmonary fibrosis.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-02-19
• Study First Submitted QC: 2008-02-19
• Study First Posted: 2008-02-28
• Primary Completion: 2009-06
• Study Completion: 2009-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-02
• Last Update Posted: 2018-03-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Idiopathic Pulmonary Fibrosis referred for lung transplantation
• Minimum 50 meter 6 minute walk distance
• No significant underlying liver disease

Exclusion Criteria

• Significant liver disease or cirrhosis
• non ambulatory
• previous adverse reaction/allergy to Bosentan

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment with bosentan	bosentan	patients with resting or exercise induced PAH receive bosentan in a randomized open label fashion

Primary Outcome Measures

Name	Time	Method
6 minute walk distance	monthly assessement until date of lung transplantation	ATS Guideline 6MW distance before and after intervention

Secondary Outcome Measures

Name	Time	Method
chemokine peripheral blood analysis	monthly	battery of chemokines analyzed from the peripheral blood
right heart catheterization hemodynamics	variable based on time between listing and actual lung transplantation	pulmonary hemodynamics

Trial Locations

Locations (2)

David Geffen School of Medicine UCLA; 🇺🇸 Los Angeles, California, United States

Departments of Pulmonary and Critical Care, Cardiothoracic Surgery and Infectious Diseases at David Geffen School of Medicine at UCLA; 🇺🇸 Los Angeles, California, United States