Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil

Sponsor

University of California, Los Angeles (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00625079

Collaborator

Pfizer (Industry)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Arterial Hypertension Idiopathic Pulmonary Fibrosis Interstitial Lung Disease Pulmonary Hypertension	Drug: sildenafil	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2007

Anticipated Primary Completion Date :

Jun 1, 2009

Anticipated Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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	Drug: sildenafil the dose of sildenafil will be 20mg three times per day (orally) Other Names: Revatio
Experimental: Pre-transplant sildenafil There are two active comparators, one group with resting PAH and another with exercise PAH, both receiving drug.	Drug: sildenafil the dose of sildenafil will be 20mg three times per day (orally) Other Names: Revatio
No Intervention: 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

Arm

Intervention/Treatment

Placebo Comparator: 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

Drug: sildenafil

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

Other Names:

Revatio

Experimental: Pre-transplant sildenafil

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

Drug: sildenafil

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

Other Names:

Revatio

No Intervention: 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

Outcome Measures

Primary Outcome Measures

6 minute walk distance (6MWD) change from Baseline [6 months]
ATS guideline based 6MW distance

Secondary Outcome Measures

Right heart catheterization hemodynamics [initial right heart catheterization compared to catheterization done on day of lung transplantation; we will specifically compare mean pulmonary artery pressure, pulmonary vascular resistance, and pulmonary artery wedge pressure]
pulmonary hemodynamics via invasive right heart catheterization
Chemokine analysis on peripheral blood [the chemokines will be quantified and compared between study entry and the time point just prior to lung transplantation]
evaluation of a group of chemokines before and after the intervention in each arm
Quality of life assessment [study entry compared to 6 months or at the time of lung transplantation (whichever comes first); there is a 0-100 scoring scale and the lower the score, the more disability]
SF-36 (short-form 36)
Quality of life assessment in the context of dyspnea [the SGRQ will be be compared at two time points, study entry and at 6 months or the time of transplantation (whichever comes first); scores range from 0 to 100 and higher scores indicate more limitation]
Saint George Respiratory Questionnaire (SGRQ)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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