Status:
COMPLETED
Tadalafil for Pulmonary Hypertension Due to Chronic Lung Disease
Lead Sponsor:
VA Office of Research and Development
Conditions:
Pulmonary Hypertension
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40-85 years
Phase:
PHASE2
Brief Summary
The functional, social, and economic burden of chronic obstructive lung disease (COPD) on the healthcare system is extraordinary. COPD is the fourth leading cause of death in the United States, and so...
Detailed Description
Project Summary/Abstract This VA CSR\&D Merit Review Award for a Clinical Trial proposal describes a 5-year program to support a prospective, placebo-controlled, randomized clinical trial (RCT) evalua...
Eligibility Criteria
Inclusion
- Male and female U.S. Veteran patients 40-85 years old, with Gold Stage II COPD by pulmonary function testing (FEV1/FVC \<0.70; performed within 6 months of recruitment.
- Eligible subjects must have PH documented on transthoracic echocardiogram within 6 months of baseline visit demonstrating an RV systolic pressure \>40mmHg. To confirm the presence of PH, a right-heart catheterization will be performed, with subjects randomized to treatment only if catheterization shows a:
- mPAP \>25 mm Hg
- PVR \>2.5 Wood units
- pulmonary artery capillary wedge pressure 18 mm Hg or less at rest
- PH belonging to the following subgroup of the updated Dana Point Clinical Classification:
- Group 3 (PH associated with lung disease and/or hypoxemia) specifically, Group 3.1 (chronic obstructive pulmonary disease \[COPD\]) as the major criteria. Patients may also have minor clinical features associated with 3.2 (Interstitial disease) (such as mild fibrosis on high resolution chest CT, but total lung capacity\>80% predicted) and 3.3 (sleep disordered breathing) (AHI \<15 or 20/hour).
- 6-minute walk distance between 50-450 meters at screening visit.
Exclusion
- PH belonging to the following subgroups of the updated Dana Point Clinical Classification:
- Group 1
- Idiopathic
- heritable
- drug or toxin-induced
- Associated Pulmonary Arterial Hypertension (APAH) with:
- connective tissue disease
- congenital heart disease
- or HIV
- Group 2
- left atrial hypertension
- Group 4
- chronic thromboembolic PH
- or other forms of PH not associated with primary lung disease
- Also
- Patients with a history of systemic hypotension in the ambulatory setting (reproducible measurements of systolic blood pressure \<89 mmHg) on chart review.
- Patients with moderate or severe hepatic impairment (Child-Pugh B and C)
- Patients with severe renal insufficiency (GFR \<30 ml/min/1.73 m2)
- Severe aortic stenosis (aortic valve area \<1.0 cm2)
- Patients with any acute or chronic impairment:
- (other than dyspnea), limiting the ability to comply with the study requirements, including the 6-minute walk test and right heart catheterization.
- Patients with a recent stroke
- Patients with untreated hypoxemia (SaO2 \<92%) at rest
- Patients with untreated moderate or severe obstructive sleep apnea (AHI\>15)
- Patients with any coagulopathy
- Patients requiring nitrate therapy for any clinical indication
- Patients with an active prescription for pulmonary vasodilator medication other than oxygen
- Patients with a history of nonarteritic anterior ischemic optic neuropathy
- Contraindication to tadalafil use including allergy to:
- any PDE-5 inhibitor
- anatomical deformations of the penis
- sickle cell anemia
- multiple myeloma
- leukemia
- bleeding disorders
- active peptic ulcer disease
- retinitis pigmentosa or other retinal disorders.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2019
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01862536
Start Date
October 1 2013
End Date
August 31 2019
Last Update
March 9 2021
Active Locations (5)
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1
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073
2
VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, United States, 80220
3
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033
4
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130