Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Heart Failure With Preserved Ejection Fraction
Public ClinicalTrials.gov record NCT03037580. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) in Heart Failure With Preserved Ejection Fraction (HFpEF)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This was a multicenter, randomized (1:1; oral treprostinil to placebo), double-blind, placebo-controlled study in subjects with World Health Organization (WHO) Group 2 pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF). Once randomized, subjects took the initial dose of study drug at the study site on the day of randomization. Subjects returned to the study site for visits scheduled at Weeks 6, 12, 18, and 24. The duration of study participation was approximately 28 weeks from Screening until study completion (includes a 30-day Screening Phase and 24-week Treatment Phase). The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment. As only a small portion of the anticipated total subjects had been enrolled, with many terminating early due to the study termination, there was a limited ability to explore the effect of oral treprostinil in this indication in this study.
Study identification
- NCT ID
- NCT03037580
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 84 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 15, 2017 (Actual)
- Primary completion
- Dec 3, 2019 (Actual)
- Completion
- Dec 3, 2019 (Actual)
- Last update posted
- Nov 10, 2020
2017 – 2019
United States locations
- U.S. sites
- 82
- U.S. states
- 32
- U.S. cities
- 69
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Banner University Medical Center Phoenix | Phoenix | Arizona | 85006 | — |
| University of Arizona | Tucson | Arizona | 85724 | — |
| VA Healthcare System of Greater Los Angeles | Los Angeles | California | 90073 | — |
| University of California Los Angeles Pulmonary Division | Los Angeles | California | 90095 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90211 | — |
| University of California - Davis Medical Center | Sacramento | California | 95817 | — |
| Santa Barbara Cottage Hospital | Santa Barbara | California | 93105 | — |
| Aurora Denver Cardiology Associates | Aurora | Colorado | 80012 | — |
| University of Colorado Denver | Aurora | Colorado | 80045 | — |
| National Jewish Health | Denver | Colorado | 80206 | — |
| South Denver Cardiology | Littleton | Colorado | 80120 | — |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| Medical Faculty Associates, George Washington University | Washington D.C. | District of Columbia | 20037 | — |
| Bay Area Cardiology Associates | Brandon | Florida | 33511 | — |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | — |
| St. Vincent's Lung, Sleep, and Critical Care Specialists | Jacksonville | Florida | 33204 | — |
| Central Florida Pulmonary Group, P.A. | Orlando | Florida | 32803 | — |
| Florida Hospital | Orlando | Florida | 32806 | — |
| University of South Florida; Tampa General Hospital | Tampa | Florida | 33606 | — |
| Cleveland Clinic of Florida | Weston | Florida | 33331 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| Augusta University | Augusta | Georgia | 30912 | — |
| Piedmont Physicians Georgia Lung | Austell | Georgia | 30309 | — |
| WellStar Medical Group | Marietta | Georgia | 30060 | — |
| University of Illinois at Chicago Hospital | Chicago | Illinois | 60612 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | — |
| OSF HealthCare | Peoria | Illinois | 61614 | — |
| Indiana University Health Methodist Research Institute, INC | Indianapolis | Indiana | 46202 | — |
| Community Physician Network, Heart and Vascular Care | Indianapolis | Indiana | 46250 | — |
| Saint Vincent Hospital and Health Services | Indianapolis | Indiana | 46260 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 55242 | — |
| Iowa Heart Center | West Des Moines | Iowa | 50266 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | — |
| Kentuckiana Pulmonary Associates | Louisville | Kentucky | 40202 | — |
| University of Louisville Physicians Outpatient Center | Louisville | Kentucky | 40202 | — |
| Chest Medicine Associates | South Portland | Maine | 04106 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| St. Elizabeth's Medical Center | Brighton | Massachusetts | 02135 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Spectrum Health Medical Group | Grand Rapids | Michigan | 49503 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| St. Luke's Hospital | Chesterfield | Missouri | 63017 | — |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Barnabas Health Lung Center | Newark | New Jersey | 07112 | — |
| Albany Medical College | Albany | New York | 12208 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| Pulmonary Health Physicians, PC | Syracuse | New York | 13066 | — |
| Montefiore Medical Center | The Bronx | New York | 10461 | — |
| Asheville Cardiology Associates | Asheville | North Carolina | 28803 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Pinehurst Medical Clinic | Pinehurst | North Carolina | 28374 | — |
| The Lindner Research Center The Christ Hospital Health Network | Cincinnati | Ohio | 45219 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | — |
| University of Toledo Medical Center | Toledo | Ohio | 43614 | — |
| The Oregon Clinic | Portland | Oregon | 97225 | — |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17601 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| AnMed Health Pulmonary and Sleep Medicine | Anderson | South Carolina | 29621 | — |
| VitaLink Research - Anderson | Anderson | South Carolina | 29621 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Stern Cardiovascular Foundation | Germantown | Tennessee | 38138 | — |
| Summit Medical Group | Knoxville | Tennessee | 37909 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Baylor University Medical Center | Dallas | Texas | 75246 | — |
| Houston Methodist Research Institute | Houston | Texas | 77030 | — |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
| Texas Tech University Health Sciences Center | Lubbock | Texas | 79905 | — |
| Intermountain Medical Center | Murray | Utah | 84157-7000 | — |
| Inova Heart and Vascular Institute | Falls Church | Virginia | 22042 | — |
| Sentara Cardiovascular Research Institute | Norfolk | Virginia | 23507 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
| Carilion Clinic | Roanoke | Virginia | 24014 | — |
| Providence Medical Research Center | Spokane | Washington | 99204 | — |
| West Virginia University Hospital | Morgantown | West Virginia | 26506 | — |
| Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03037580, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 10, 2020 · Synced Oct 28, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03037580 live on ClinicalTrials.gov.