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Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil

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ClinicalTrials.gov Identifier: NCT00625079
Recruitment Status : Withdrawn (inclusion/exclusion criteria limited enrollment)
First Posted : February 28, 2008
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of California, Los Angeles

February 19, 2008
February 28, 2008
May 1, 2018
February 2007
June 2009   (Final data collection date for primary outcome measure)
6 minute walk distance (6MWD) change from Baseline [ Time Frame: 6 months ]
ATS guideline based 6MW distance
6 minute walk distance [ Time Frame: monthly until date of lung transplantation ]
Complete list of historical versions of study NCT00625079 on ClinicalTrials.gov Archive Site
  • Right heart catheterization hemodynamics [ 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 ]
    pulmonary hemodynamics via invasive right heart catheterization
  • Chemokine analysis on peripheral blood [ Time Frame: 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
  • Quality of life assessment [ 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 ]
    SF-36 (short-form 36)
  • Quality of life assessment in the context of dyspnea [ 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 ]
    Saint George Respiratory Questionnaire (SGRQ)
  • Right heart catheterization hemodynamics [ Time Frame: initial right heart catheterization compared to catheterization done on day of lung transplantation ]
  • Chemokine analysis on peripheral blood [ Time Frame: monthly ]
  • Quality of life assessment [ Time Frame: monthly ]
Not Provided
Not Provided
 
Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil
Randomized Placebo-Controlled Study of Sildenafil For The Treatment of Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis: A Pilot Study
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Pulmonary Arterial Hypertension
  • Idiopathic Pulmonary Fibrosis
  • Interstitial Lung Disease
  • Pulmonary Hypertension
Drug: sildenafil
the dose of sildenafil will be 20mg three times per day (orally)
Other Name: Revatio
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
50
December 2009
June 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00625079
IPF/PH
Yes
Not Provided
Not Provided
University of California, Los Angeles
University of California, Los Angeles
Pfizer
Study Director: Rajan Saggar, MD David Geffen School of Medicine, UCLA
University of California, Los Angeles
March 2018

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