Status:
COMPLETED
Sildenafil to Increase Exercise Capacity in Individuals With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Pulmonary Fibrosis
Hypertension, Pulmonary
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease that affects an individual's ability to breathe. Currently, no medications can reverse the damage to the lungs caused by IPF, but individu...
Detailed Description
IPF is a disease that damages the air sacs in the lungs and leads to widespread and permanent scarring of lung tissue. Individuals with IPF may experience breathing difficulties, cough, chest pain, an...
Eligibility Criteria
Inclusion
- IPF, diagnosed according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) consensus statement (with or without surgical lung biopsy)
- Pulmonary hypertension, defined as mean pulmonary artery pressure (MPAP) greater than or equal to 25 mm Hg by right heart catheterization (RHC)
Exclusion
- Interstitial lung disease due to conditions other than IPF
- Recent lung or upper respiratory tract infection within 4 weeks of study entry
- Acute or chronic impairment other than dyspnea (e.g., angina pectoris, intermittent claudication) limiting the ability to comply with study requirements (e.g., 6-minute walk test)
- Known hypersensitivity to sildenafil
- Known or suspected coronary artery disease (CAD)
- Unstable angina
- Nitrate use
- Known or suspected aortic stenosis (AS)
- Known or suspected heart attack, stroke, or life-threatening arrythmias within 1 month of study entry
- Severe chronic heart failure, defined as New York Heart Association (NYHA) class III/IV and/or left ventricular ejection fraction less than 25%
- Known penile deformities
- Known kidney or liver dysfunction
- Uncontrolled diabetes (blood glucose less than 60 mg/dl or greater than 300 mg/dl)
- Severe serum sodium abnormalities (serum sodium less than 130 mEq/L or greater than 150 mEq/L)
- Condition that may predispose participant to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia)
- Retinitis pigmentosa
- Known or suspected idiopathic hypertrophic subaortic stenosis (IHSS)
- Low blood pressure (systolic blood pressure \[SBP\] less than 100 mm Hg or diastolic blood pressure \[DBP\] less than 50 mm Hg)
- Uncontrolled systemic high blood pressure (SBP greater than 180 mm Hg or DBP greater than 100 mm Hg)
- Cardiopulmonary rehabilitation program started within 8 weeks of study entry or likely to start prior to the conclusion of the study
- Treatment with an endothelin receptor antagonist, iloprost, epoprostenol, inhibitors of CYP3A4 (e.g., cimetidine, erythromycin, ketoconazole, itraconazole, mibefradil), protease inhibitors (e.g., amprenavir, indinavir, or ritonavir), rifampin, alpha-blockers (e.g., doxazosin), or other phosphodiesterase-5 inhibitors
- Current use of alcohol, grapefruit juice, or St. John's wort
- Pregnant or breastfeeding
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00352482
Start Date
November 1 2004
End Date
July 1 2007
Last Update
July 29 2016
Active Locations (1)
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1
UCLA Pulmonary Outpatient Clinic,
Los Angeles, California, United States, 90095