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 hemodynamicschemokine 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
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