Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil

NCT00625079

Last updated date
Study Location
David Geffen School of Medicine UCLA
Los Angeles, California, 90095-1690, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Arterial Hypertension, Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease, Pulmonary Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Non ambulatory


- Prior adverse reaction/allergy to sildenafil or other PDE-5 Inhibitors


- Any other pulmonary vasodilator within one month of enrollment

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Pulmonary Arterial Hypertension, Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease, Pulmonary HypertensionPulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil
NCT00625079
  1. Los Angeles, California
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil
Official Title  ICMJE Randomized Placebo-Controlled Study of Sildenafil For The Treatment of Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis: A Pilot Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pulmonary Arterial Hypertension
  • Idiopathic Pulmonary Fibrosis
  • Interstitial Lung Disease
  • Pulmonary Hypertension
Intervention  ICMJE Drug: sildenafil
the dose of sildenafil will be 20mg three times per day (orally)
Other Name: Revatio
Study Arms  ICMJE
  • 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
    Intervention: Drug: sildenafil
  • Experimental: Pre-transplant sildenafil
    There are two active comparators, one group with resting PAH and another with exercise PAH, both receiving drug.
    Intervention: Drug: sildenafil
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 2, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2008)
50
Estimated Study Completion Date  ICMJE December 2009
Estimated Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00625079
Other Study ID Numbers  ICMJE IPF/PH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Rajan Saggar, MDDavid Geffen School of Medicine, UCLA
PRS Account University of California, Los Angeles
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP