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NCT00625469 Clinical Trial

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

Pulmonary Arterial Hypertension Clinical Trial

Official title:
Treatment of Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Hypertension With Bosentan: A Single Center Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00625469
Other study ID # IPF/PAH
Secondary ID
Status Withdrawn
Phase Phase 4
First received February 19, 2008
Last updated March 2, 2018
Start date October 2007
Est. completion date December 2009

Study information
Verified date March 2018
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• bosentan
62.5mg orally bid for first month, followed by 125mg bid thereafter

Locations
Country Name City State
United States 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

Sponsors (2)
Lead Sponsor Collaborator
Rajan Saggar Actelion

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 6 minute walk distance ATS Guideline 6MW distance before and after intervention monthly assessement until date of lung transplantation
Secondary right heart catheterization hemodynamics pulmonary hemodynamics variable based on time between listing and actual lung transplantation
Secondary chemokine peripheral blood analysis battery of chemokines analyzed from the peripheral blood monthly
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