Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2008 by University of California, Los Angeles.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Pfizer

Information provided by:

University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT00625079

First received: February 19, 2008

Last updated: NA

Last verified: February 2008

History: No changes posted

Tracking Information

First Received Date ^ICMJE

February 19, 2008

Last Updated Date

February 19, 2008

Start Date ^ICMJE

February 2007

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil

Official Title ^ICMJE

Randomized Placebo-Controlled Study of Sildenafil For The Treatment of Pulmonary Arterial 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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Pulmonary Arterial Hypertension
Idiopathic Pulmonary Fibrosis
Interstitial Lung Disease
Pulmonary Hypertension

Intervention ^ICMJE

Drug: sildenafil
sildenafil 20mg three times per day (orally)

Other Name: Revatio
Drug: sildenafil
sildenafil (placebo) 20mg three times per day (orally)

Study Arm (s)

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

Intervention: Drug: sildenafil
Active Comparator: 2
There are two active comparators, one group with resting PAH and another with exercise PAH, both receiving drug

Intervention: Drug: sildenafil
No Intervention: 3
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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00625079

Other Study ID Numbers ^ICMJE

IPF/PH

Has Data Monitoring Committee

Yes

Responsible Party

Rajan Saggar, David Geffen School of Medicine UCLA

Study Sponsor ^ICMJE

University of California, Los Angeles

Collaborators ^ICMJE

Pfizer

Investigators ^ICMJE

Study Director:

Rajan Saggar, MD

David Geffen School of Medicine, UCLA

Information Provided By

University of California, Los Angeles

Verification Date

February 2008

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

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