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

Information source: University of California, Los Angeles
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Arterial Hypertension; Idiopathic Pulmonary Fibrosis

Intervention: bosentan (Drug); No specific intervention (Other); No specific intervention (Other)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of California, Los Angeles

Official(s) and/or principal investigator(s):
Rajan Saggar, MD, Principal Investigator, Affiliation: University of California, Los Angeles

Overall contact:
Michaela Dyke, Phone: 310-825-5635, Email: mdyke@mednet.ucla.edu

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 6 minute walk distance

Secondary outcome:

right heart catheterization hemodynamics

chemokine peripheral blood analysis

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Michaela Dyke, Phone: 310-825-5635, Email: mdyke@mednet.ucla.edu

David Geffen School of Medicine UCLA, Los Angeles, California 90095-1690, United States; Recruiting
Michaela Dyke, Phone: 310-825-5635, Email: mdyke@mednet.ucla.edu

Departments of Pulmonary and Critical Care, Cardiothoracic Surgery and Infectious Diseases at David Geffen School of Medicine at UCLA, Los Angeles, California 90095-1690, United States; Recruiting
Rajan Saggar, M.D., Phone: 310-825-5635, Email: rsaggar@mednet.ucla.edu
Michaela Dyke, Phone: 310-825-5635, Email: mdyke@mednet.ucla.edu
Rajan Saggar, M.D., Principal Investigator
David J Ross, M.D., Sub-Investigator
John Belperio, M.D., Sub-Investigator
Joseph P Lynch, III, M.D., Sub-Investigator
Abbas Ardehali, M.D., Sub-Investigator
Rajeev Saggar, MD, Sub-Investigator
David Zisman, MD, Sub-Investigator

Additional Information

Starting date: October 2007
Last updated: February 19, 2008

Page last updated: August 23, 2015

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