Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil

Brief Title

Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil

Official Title

Randomized Placebo-Controlled Study of Sildenafil For The Treatment of Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis: A Pilot Study

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 sildenafil 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 is to evaluate the use of sildenafil in patients with pulmonary
      fibrosis and PH being considered for lung transplantation. We hypothesize that not only will
      sildenafil improve functionality and QOL in the pre-transplant setting but it may also
      improve primary graft dysfunction after lung transplantation.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

6 minute walk distance (6MWD) change from Baseline

Secondary Outcome

 Right heart catheterization hemodynamics

Condition

Pulmonary Arterial Hypertension

Intervention

sildenafil

Study Arms / Comparison Groups

 Pre-transplant placebo
Description:  There are two placebo comparators.... one for the group of patients with resting PAH and another for the group of patients with exercise PAH

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

0

Start Date

February 2007

Completion Date

December 2009

Primary Completion Date

June 2009

Eligibility Criteria

        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

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Rajan Saggar, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00625079

Organization ID

IPF/PH


Responsible Party

Sponsor

Study Sponsor

University of California, Los Angeles

Collaborators

 Pfizer

Study Sponsor

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


Verification Date

March 2018