Back to resultsPulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil
Primary Purpose
Pulmonary Arterial Hypertension, Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
sildenafil
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring pulmonary hypertension, pulmonary arterial hypertension, interstitial lung disease, idiopathic pulmonary fibrosis
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
Sites / Locations
- David Geffen School of Medicine UCLA
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
No Intervention
Arm Label
Pre-transplant placebo
Pre-transplant sildenafil
Pre-transplant no PAH-specific therapy
Arm Description
There are two placebo comparators.... one for the group of patients with resting PAH and another for the group of patients with exercise PAH
There are two active comparators, one group with resting PAH and another with exercise PAH, both receiving drug.
this group of patients has no evidence for either resting or exercise PAH but will be followed without specific drug intervention
Outcomes
Primary Outcome Measures
6 minute walk distance (6MWD) change from Baseline
ATS guideline based 6MW distance
Secondary Outcome Measures
Right heart catheterization hemodynamics
pulmonary hemodynamics via invasive right heart catheterization
Chemokine analysis on peripheral blood
evaluation of a group of chemokines before and after the intervention in each arm
Quality of life assessment
SF-36 (short-form 36)
Quality of life assessment in the context of dyspnea
Saint George Respiratory Questionnaire (SGRQ)
Full Information
NCT ID
NCT00625079
First Posted
February 19, 2008
Last Updated
April 27, 2018
Sponsor
University of California, Los Angeles
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00625079
Brief Title
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
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Withdrawn
Why Stopped
inclusion/exclusion criteria limited enrollment
Study Start Date
February 2007 (Actual)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Los Angeles
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension, Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease, Pulmonary Hypertension
Keywords
pulmonary hypertension, pulmonary arterial hypertension, interstitial lung disease, idiopathic pulmonary fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre-transplant placebo
Arm Type
Placebo Comparator
Arm Description
There are two placebo comparators.... one for the group of patients with resting PAH and another for the group of patients with exercise PAH
Arm Title
Pre-transplant sildenafil
Arm Type
Experimental
Arm Description
There are two active comparators, one group with resting PAH and another with exercise PAH, both receiving drug.
Arm Title
Pre-transplant no PAH-specific therapy
Arm Type
No Intervention
Arm Description
this group of patients has no evidence for either resting or exercise PAH but will be followed without specific drug intervention
Intervention Type
Drug
Intervention Name(s)
sildenafil
Other Intervention Name(s)
Revatio
Intervention Description
the dose of sildenafil will be 20mg three times per day (orally)
Primary Outcome Measure Information:
Title
6 minute walk distance (6MWD) change from Baseline
Description
ATS guideline based 6MW distance
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Right heart catheterization hemodynamics
Description
pulmonary hemodynamics via invasive right heart catheterization
Time Frame
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
Title
Chemokine analysis on peripheral blood
Description
evaluation of a group of chemokines before and after the intervention in each arm
Time Frame
the chemokines will be quantified and compared between study entry and the time point just prior to lung transplantation
Title
Quality of life assessment
Description
SF-36 (short-form 36)
Time Frame
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
Title
Quality of life assessment in the context of dyspnea
Description
Saint George Respiratory Questionnaire (SGRQ)
Time Frame
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajan Saggar, MD
Organizational Affiliation
David Geffen School of Medicine, UCLA
Official's Role
Study Director
Facility Information:
Facility Name
David Geffen School of Medicine UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1690
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil
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