Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil

NCT00625079 | Withdrawn Phase 4 DMC

• 1 other identifier: IPF/PH
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension; Idiopathic Pulmonary Fibrosis; Interstitial Lung Disease; Pulmonary Hypertension

Keywords

pulmonary hypertension; pulmonary arterial hypertension; interstitial lung disease; idiopathic pulmonary fibrosis

Outcome Measures

Primary Outcomes (1)

• 6 minute walk distance (6MWD) change from Baseline

  ATS guideline based 6MW distance

  6 months

Secondary Outcomes (4)

• Right heart catheterization hemodynamics

  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

• Chemokine analysis on peripheral blood

  the chemokines will be quantified and compared between study entry and the time point just prior to lung transplantation

• Quality of life assessment

  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

• Quality of life assessment in the context of dyspnea

  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

Study Arms (3)

Pre-transplant placebo

PLACEBO COMPARATOR

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

Pre-transplant sildenafil

EXPERIMENTAL

There are two active comparators, one group with resting PAH and another with exercise PAH, both receiving drug.

Drug: sildenafil

Pre-transplant no PAH-specific therapy

NO INTERVENTION

this group of patients has no evidence for either resting or exercise PAH but will be followed without specific drug intervention

Interventions

sildenafil DRUG

the dose of sildenafil will be 20mg three times per day (orally)

Also known as: Revatio

Pre-transplant placebo; Pre-transplant sildenafil

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non ambulatory
• Prior adverse reaction/allergy to sildenafil or other PDE-5 Inhibitors
• Any other pulmonary vasodilator within one month of enrollment

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Pfizer: collaborator

Study Sites (1)

David Geffen School of Medicine UCLA

Los Angeles, California, 90095-1690, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial; Hypertension, Pulmonary

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Pulmonary Fibrosis; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Rajan Saggar, MD

  David Geffen School of Medicine, UCLA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 28, 2008
• Study Start: February 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 1, 2018

Record last verified: 2018-03

Locations

US (1)