Tadalafil for Pulmonary Hypertension Due to Chronic Lung Disease (TADA-PHILD)
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 some estimates attribute up to $33.2 billion in health care costs to COPD-associated morbidity and mortality annually. The burden of COPD to the VA Healthcare system parallels these findings. According to the VA HSR&D Health Economics Resource Center, COPD ranks 5th among the 40 most common chronic clinical conditions in the U.S. Veteran patient population, is responsible for >14,000 VA hospital admission annually, and increases by $1,051/patient the total annual health care cost burden on the VA Healthcare system. Importantly, COPD is associated with frequent emergency room visitation and/or hospitalization patients. Pulmonary hypertension is a common co-morbid condition that worsen morbidity and mortality in patients with COPD. This study will examine the potential for tadalafil, a phosphodiesterase type-5 (PDE-5) inhibitor to improve functional status by decreasing pulmonary hypertension. Results from this study are expected to define the potential use of PDE-5 inhibitors in COPD-induced pulmonary hypertension. If successful, this treatment option may improve quality of life and outcomes for the large number of veterans afflicted with PH due to COPD.
Chronic Obstructive Pulmonary Disease (COPD)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Tadalafil for Pulmonary Hypertension Associated With Chronic Lung Disease|
- Change in 6 minute walk test [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Change from baseline in distance walked in 6 minutes.
- Maximum volume of oxygen extraction on exercise testing [ Time Frame: 12 months ] [ Designated as safety issue: No ]Measure of aerobic fitness on exercise
- Pulmonary vascular resistance [ Time Frame: 6 months ] [ Designated as safety issue: No ]Pulmonary vascular resistance assessed on right heart catheterization is a hemodynamic measurement of pulmonary vascular remodeling.
- Mean pulmonary artery pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]Mean pulmonary artery pressure assessed by right heart catheterization is a hemodynamic measurement of pulmonary hypertension severity.
- Tricuspid annular plane excursion (TAPSE) [ Time Frame: 12 months ] [ Designated as safety issue: No ]The tricuspid annular plane excursion is an echocardiographic measurement of right ventricular systolic dysfunction.
- Dyspnea and health related quality of life (HRQL) [ Time Frame: 12 months ] [ Designated as safety issue: No ]Survey-based assessment of patient-reported changes to symptoms and quality of life following study drug treatment.
- N-type brain natriuretic peptide (BNP) concentration [ Time Frame: 12 months ] [ Designated as safety issue: No ]Plasma BNP concentration is a biochemical marker that correlates positively with pulmonary hypertension severity.
- Resting Hypoxemia [ Time Frame: Early (4 hours and 3 days following treatment) and late (1, 3, 6, 9, 12 months following treatment) ] [ Designated as safety issue: Yes ]Changes to resting peripheral oxyhemoglobin saturation levels will be used to assess the safety of the study drug in patients with chronic lung diseases.
- Exercise-induced hypoxemia [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Changes to peripheral oxyhemoglobin saturation levels on exercise will be used to assess the safety of the study drug in patients with chronic lung diseases.
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||August 2018|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Daily use in double blind study.
Daily use of tadalafil (study drug) at 40 mg orally.
Daily use of study drug to treat pulmonary hypertension.
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|Contact: Ronald H Goldstein, MD||(857) 203-6578||Ronald.Goldstein@va.gov|
|Contact: Bradley A Maron, MD||(617) firstname.lastname@example.org|
|United States, California|
|VA Greater Los Angeles Healthcare System, West Los Angeles, CA||Recruiting|
|West Los Angeles, California, United States, 90073|
|Contact: Shelley Shapiro 310-268-4314 email@example.com|
|United States, Massachusetts|
|VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA||Recruiting|
|Boston, Massachusetts, United States, 02130|
|Contact: Paul R Conlin, MD (857) 203-5111 Paul.Conlin@va.gov|
|Contact: Terence M Keane, PhD (857) 364-4551 firstname.lastname@example.org|
|Principal Investigator: Ronald Howard Goldstein, MD|
|United States, Rhode Island|
|Providence VA Medical Center, Providence, RI||Recruiting|
|Providence, Rhode Island, United States, 02908|
|Contact: Sharon I Rounds 401-457-3020 email@example.com|
|Principal Investigator:||Ronald Howard Goldstein, MD||VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA|