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Recruitment Status : Withdrawn (inclusion/exclusion criteria limited enrollment)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

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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Idiopathic Pulmonary Fibrosis Interstitial Lung Disease Pulmonary Hypertension Drug: sildenafil Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Placebo-Controlled Study of Sildenafil For The Treatment of Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis: A Pilot Study
Actual Study Start Date : February 2007
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : December 2009


Arm Intervention/treatment
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
Drug: sildenafil
the dose of sildenafil will be 20mg three times per day (orally)
Other Name: Revatio

Experimental: Pre-transplant sildenafil
There are two active comparators, one group with resting PAH and another with exercise PAH, both receiving drug.
Drug: sildenafil
the dose of sildenafil will be 20mg three times per day (orally)
Other Name: Revatio

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



Primary Outcome Measures :
  1. 6 minute walk distance (6MWD) change from Baseline [ Time Frame: 6 months ]
    ATS guideline based 6MW distance


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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)

  4. 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)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00625079


Locations
United States, California
David Geffen School of Medicine UCLA
Los Angeles, California, United States, 90095-1690
Sponsors and Collaborators
University of California, Los Angeles
Pfizer
Investigators
Study Director: Rajan Saggar, MD David Geffen School of Medicine, UCLA

Responsible Party: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00625079     History of Changes
Other Study ID Numbers: IPF/PH
First Posted: February 28, 2008    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: March 2018

Keywords provided by University of California, Los Angeles:
pulmonary hypertension
pulmonary arterial hypertension
interstitial lung disease
idiopathic pulmonary fibrosis

Additional relevant MeSH terms:
Lung Diseases
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Hypertension
Fibrosis
Pathologic Processes
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents