Clinical trial NCT00625079: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pulmonary Arterial Hypertension
Idiopathic Pulmonary Fibrosis
Interstitial Lung Disease
Pulmonary Hypertension
Keywords: pulmonary hypertension
pulmonary arterial hypertension
interstitial lung disease
idiopathic pulmonary fibrosis
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-02-28
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 6 minute walk distance (6MWD) change from Baseline
timeFrame: 6 months
Secondary outcomes:
measure: Right heart catheterization hemodynamics
timeFrame: 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
measure: Chemokine analysis on peripheral blood
timeFrame: the chemokines will be quantified and compared between study entry and the time point just prior to lung transplantation
measure: Quality of life assessment
timeFrame: 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
measure: Quality of life assessment in the context of dyspnea
timeFrame: 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
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: David Geffen School of Medicine UCLA
state: California
Study officials:
affiliation: David Geffen School of Medicine, UCLA
name: Rajan Saggar, MD
role: STUDY_DIRECTOR
References: