Official Title: “Randomized Placebo-Controlled Study of Sildenafil For The Treatment of Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis: A Pilot Study”

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 sildenafil may improve morbidity and mortality in the peri-LT setting in both IPF cohorts with either resting or exercise PAH.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2009

Intervention(s) in this Clinical Trial

• Drug: sildenafil
  • sildenafil 20mg three times per day (orally)
• Drug: sildenafil
  • sildenafil (placebo) 20mg three times per day (orally)

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • There are two placebo comparators.... one for the group of patients with resting PAH and another for the group of patients with exercise PAH
• Active Comparator: 2
  • There are two active comparators, one group with resting PAH and another with exercise PAH, both receiving drug
• No Intervention: 3
  • this group of patients has no evidence for either resting or exercise PAH but will be followed without specific drug intervention

Primary Measures

• 6 minute walk distance
  • Time Frame: monthly until date of lung transplantation
    Safety Issue?: No

Secondary Measures

• Right heart catheterization hemodynamics
  • Time Frame: initial right heart catheterization compared to catheterization done on day of lung transplantation
    Safety Issue?: No
• chemokine analysis on peripheral blood
  • Time Frame: monthly
    Safety Issue?: No
• quality of life assessment
  • Time Frame: monthly
    Safety Issue?: No

Inclusion Criteria:

• Patients with Idiopathic Pulmonary Fibrosis referred for lung transplantation at our medical center
• Minimal 6 minute walk distance of 50 meters; must be able to conduct supine exercise during heart catheterization

Exclusion Criteria:

• Non ambulatory
• Prior adverse reaction/allergy to sildenafil or other PDE-5 Inhibitors
• Any other pulmonary vasodilator within one month of enrollment

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of California, Los Angeles

Overall Clinical Trial Officials and Contacts

Rajan Saggar, MD Study Director David Geffen School of Medicine, UCLA  

Overall Contact: Rajan Saggar, MD 310-825-5635 rsaggar@mednet.ucla.edu

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00625079

Study ID Number: IPF/PH

ClinicalTrials.gov Identifier: NCT00625079

Health Authority: United States: Food and Drug Administration