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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01862536|
Recruitment Status : Recruiting
First Posted : May 24, 2013
Last Update Posted : December 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension Chronic Obstructive Pulmonary Disease (COPD)||Drug: Tadalafil Drug: placebo||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 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|
|Estimated Primary Completion Date :||August 31, 2018|
|Estimated 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.
- Change in 6 minute walk test [ Time Frame: 12 months ]Change from baseline in distance walked in 6 minutes.
- Maximum volume of oxygen extraction on exercise testing [ Time Frame: 12 months ]Measure of aerobic fitness on exercise
- 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.
- Dyspnea and health related quality of life (HRQL) [ Time Frame: 12 months ]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 ]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
|Contact: Ronald H Goldstein, MD||(857) 203-6578||Ronald.Goldstein@va.gov|
|Contact: Bradley A Maron, MD||(617) email@example.com|
|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 firstname.lastname@example.org|
|United States, Colorado|
|VA Eastern Colorado Health Care System, Denver, CO||Recruiting|
|Denver, Colorado, United States, 80220|
|Contact: Edward Dempsey, MDiv 303-399-6020 ext 2743 email@example.com|
|Contact: Barbara Watson, RN 303.3996020 firstname.lastname@example.org|
|United States, Georgia|
|Atlanta VA Medical and Rehab Center, Decatur, GA||Recruiting|
|Decatur, Georgia, United States, 30033|
|Contact: Ruxana Sadikot 312-636-8872 email@example.com|
|United States, Massachusetts|
|VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA||Recruiting|
|Boston, Massachusetts, United States, 02130|
|Contact: Ronald H Goldstein, MD (857) 203-6578 Ronald.Goldstein@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|