Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil

Phase 4

Withdrawn

• Conditions: Idiopathic Pulmonary Fibrosis; Interstitial Lung Disease; Pulmonary Arterial Hypertension; Pulmonary Hypertension
• Interventions: Drug: sildenafil

• Registration Number: NCT00625079
• Lead Sponsor: University of California, Los Angeles

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 Timeline

• Study Start: 2007-02
• Study First Submitted: 2008-02-19
• Study First Submitted QC: 2008-02-19
• Study First Posted: 2008-02-28
• Primary Completion: 2009-06
• Study Completion: 2009-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-04-27
• Last Update Posted: 2018-05-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-transplant sildenafil	sildenafil	There are two active comparators, one group with resting PAH and another with exercise PAH, both receiving drug.
Pre-transplant placebo	sildenafil	There are two placebo comparators.... one for the group of patients with resting PAH and another for the group of patients with exercise PAH

Primary Outcome Measures

Name	Time	Method
6 minute walk distance (6MWD) change from Baseline	6 months	ATS guideline based 6MW distance

Secondary Outcome Measures

Name	Time	Method
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
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)
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

Trial Locations

Locations (1)

David Geffen School of Medicine UCLA; 🇺🇸 Los Angeles, California, United States