Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00625079
• Other study ID #: IPF/PH
• Status: Withdrawn
• Phase: Phase 4
• Start date: February 2007
• Est. completion date: December 2009

Study information

• Verified date: March 2018
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Fibrosis
• Hypertension
• Hypertension, Pulmonary
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Arterial Hypertension
• Pulmonary Fibrosis
• Pulmonary Hypertension

Intervention

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

Locations

Country	Name	City	State
United States	David Geffen School of Medicine UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 minute walk distance (6MWD) change from Baseline	ATS guideline based 6MW distance	6 months
Secondary	Right heart catheterization hemodynamics	pulmonary hemodynamics via invasive right heart catheterization	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
Secondary	Chemokine analysis on peripheral blood	evaluation of a group of chemokines before and after the intervention in each arm	the chemokines will be quantified and compared between study entry and the time point just prior to lung transplantation
Secondary	Quality of life assessment	SF-36 (short-form 36)	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
Secondary	Quality of life assessment in the context of dyspnea	Saint George Respiratory Questionnaire (SGRQ)	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