Tadalafil for Pulmonary Hypertension Due to Chronic Lung Disease (TADA-PHILD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01862536|
Recruitment Status : Completed
First Posted : May 24, 2013
Results First Posted : March 9, 2021
Last Update Posted : March 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension Chronic Obstructive Pulmonary Disease (COPD)||Drug: Tadalafil Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Tadalafil for Pulmonary Hypertension Associated With Chronic Lung Disease|
|Actual Study Start Date :||October 1, 2013|
|Actual Primary Completion Date :||August 31, 2019|
|Actual Study Completion Date :||August 31, 2019|
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.
Other Name: Cialis
- Change in 6 Minute Walk Test [ Time Frame: The change in distance walked when assessed at 3 months following trial initiation as compared to baseline, similarly at 6 months compared to baseline, at 9 months compared to baseline and at 12 months compared to baseline. ]Change from baseline in distance walked in 6 minutes.
- Maximum VO2 [ Time Frame: 12 months ]Measure of aerobic fitness on exercise assessed by cardiopulmonary exercise test.
- Pulmonary Vascular Resistance [ Time Frame: 6 months ]Pulmonary vascular resistance assessed on right heart catheterization is a hemodynamic measurement of pulmonary vascular remodeling.
- Mean Pulmonary Artery Pressure [ Time Frame: 6 months ]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 ]The tricuspid annular plane excursion is an echocardiographic measurement of right ventricular systolic dysfunction.
- St. George's Respiratory Questionnaire, Dyspnea and Health Related Quality of Life [ Time Frame: 12 months ]
Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. There are 50 items, 2 parts, (3 components). Each item is accorded a weight determined by the degree of distress accorded to each symptom or state described.
Scores range from 0-100, with higher scores indicating more limitations
- N-type Brain Natriuretic Peptide (BNP) Concentration [ Time Frame: 12 months ]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) ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01862536
|United States, California|
|VA Greater Los Angeles Healthcare System, West Los Angeles, CA|
|West Los Angeles, California, United States, 90073|
|United States, Colorado|
|VA Eastern Colorado Health Care System, Denver, CO|
|Denver, Colorado, United States, 80220|
|United States, Georgia|
|Atlanta VA Medical and Rehab Center, Decatur, GA|
|Decatur, Georgia, United States, 30033|
|United States, Massachusetts|
|VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA|
|Boston, Massachusetts, United States, 02130|
|United States, Rhode Island|
|Providence VA Medical Center, Providence, RI|
|Providence, Rhode Island, United States, 02908|
|Principal Investigator:||Ronald H Goldstein, MD||VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA|