Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00625079
• Date of registration: 19/02/2008
• Prospective Registration: No
• Primary sponsor: University of California, Los Angeles
• Public title: Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil
• Scientific title: Randomized Placebo-Controlled Study of Sildenafil For The Treatment of Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis: A Pilot Study
• Date of first enrolment: February 2007
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT00625079
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Rajan Saggar, MD
• Affiliation: David Geffen School of Medicine, UCLA

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Hypertension

Idiopathic Pulmonary Fibrosis

Interstitial Lung Disease

Pulmonary Arterial Hypertension

Intervention(s)

Drug: sildenafil

Primary Outcome(s)

6 minute walk distance (6MWD) change from Baseline [Time Frame: 6 months]

Secondary Outcome(s)

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]

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]

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]

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]

Secondary ID(s)

IPF/PH

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pfizer