Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil - Full Text View

Sponsor:	University of California, Los Angeles
Collaborator:	Pfizer
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00625079

Purpose

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	Intervention	Phase
Pulmonary Arterial Hypertension Idiopathic Pulmonary Fibrosis Interstitial Lung Disease Pulmonary Hypertension	Drug: sildenafil	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomized Placebo-Controlled Study of Sildenafil For The Treatment of Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis: A Pilot Study

Resource links provided by NLM:

Genetics Home Reference related topics: idiopathic pulmonary fibrosis pulmonary arterial hypertension

MedlinePlus related topics: Exercise and Physical Fitness High Blood Pressure Interstitial Lung Diseases Pulmonary Fibrosis Pulmonary Hypertension

Drug Information available for: Sildenafil Sildenafil citrate

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

6 minute walk distance [ Time Frame: monthly until date of lung transplantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Right heart catheterization hemodynamics [ Time Frame: initial right heart catheterization compared to catheterization done on day of lung transplantation ] [ Designated as safety issue: No ]
chemokine analysis on peripheral blood [ Time Frame: monthly ] [ Designated as safety issue: No ]
quality of life assessment [ Time Frame: monthly ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	February 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 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 sildenafil (placebo) 20mg three times per day (orally)
Active Comparator: 2 There are two active comparators, one group with resting PAH and another with exercise PAH, both receiving drug	Drug: sildenafil sildenafil 20mg three times per day (orally) Other Name: Revatio
No Intervention: 3 this group of patients has no evidence for either resting or exercise PAH but will be followed without specific drug intervention

Eligibility

Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625079

Contacts

Contact: Rajan Saggar, MD	310-825-5635	rsaggar@mednet.ucla.edu
Contact: Michaela Dyke	310-825-5635	mdyke@mednet.ucla.edu

Locations

United States, California
David Geffen School of Medicine UCLA	Recruiting
Los Angeles, California, United States, 90095-1690
Contact: Michaela Dyke 310-825-5635 mdyke@mednet.ucla.edu

Sponsors and Collaborators

University of California, Los Angeles

Pfizer

Investigators

Study Director:

Rajan Saggar, MD

David Geffen School of Medicine, UCLA

More Information

No publications provided

Responsible Party:	Rajan Saggar, David Geffen School of Medicine UCLA
ClinicalTrials.gov Identifier:	NCT00625079 History of Changes
Other Study ID Numbers:	IPF/PH
Study First Received:	February 19, 2008
Last Updated:	February 19, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:

pulmonary hypertension
pulmonary arterial hypertension
interstitial lung disease
idiopathic pulmonary fibrosis

Additional relevant MeSH terms:

Hypertension, Pulmonary
Fibrosis
Hypertension
Lung Diseases
Pulmonary Fibrosis
Lung Diseases, Interstitial
Idiopathic Pulmonary Fibrosis
Respiratory Tract Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases

Idiopathic Interstitial Pneumonias
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012