Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil

NCT ID: NCT00625079

Last Updated: 2018-05-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2009-12-31

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.

Conditions

Pulmonary Arterial Hypertension; Idiopathic Pulmonary Fibrosis; Interstitial Lung Disease; Pulmonary Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Pre-transplant placebo

There are two placebo comparators.... one for the group of patients with resting PAH and another for the group of patients with exercise PAH

Group Type: PLACEBO_COMPARATOR

sildenafil

Intervention Type: DRUG

the dose of sildenafil will be 20mg three times per day (orally)

Pre-transplant sildenafil

There are two active comparators, one group with resting PAH and another with exercise PAH, both receiving drug.

Group Type: EXPERIMENTAL

sildenafil

Intervention Type: DRUG

the dose of sildenafil will be 20mg three times per day (orally)

Pre-transplant no PAH-specific therapy

this group of patients has no evidence for either resting or exercise PAH but will be followed without specific drug intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

sildenafil

the dose of sildenafil will be 20mg three times per day (orally)

Intervention Type: DRUG

Other Intervention Names

Revatio

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rajan Saggar, MD

Role: STUDY_DIRECTOR

David Geffen School of Medicine, UCLA

Locations

David Geffen School of Medicine UCLA

Los Angeles, California, United States

Countries

United States

Other Identifiers

IPF/PH

Identifier Type: -

Identifier Source: org_study_id