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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Recruitment Status : Withdrawn (inclusion/exclusion criteria limited enrollment)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

Tracking Information
First Submitted Date  ICMJE February 19, 2008
First Posted Date  ICMJE February 28, 2008
Last Update Posted Date May 1, 2018
Actual Study Start Date  ICMJE February 2007
Estimated Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
6 minute walk distance (6MWD) change from Baseline [ Time Frame: 6 months ]
ATS guideline based 6MW distance
Original Primary Outcome Measures  ICMJE
 (submitted: February 19, 2008)
6 minute walk distance [ Time Frame: monthly until date of lung transplantation ]
Change History Complete list of historical versions of study NCT00625079 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2008)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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, MD David 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