Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEF
Public ClinicalTrials.gov record NCT03043651. 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
An Open-label Extension Study of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF) - A Long-term Follow-up to Study TDE-HF-301
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This was an open-label study to evaluate the safety of continued therapy with oral treprostinil in subjects who completed Study TDE-HF-301. This study provided long-term, open-label data regarding the effect of continued long-term oral treprostinil therapy for the treatment of pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF). Subject visits occurred at Baseline, Weeks 6, 12, 18, 24, and every 12 weeks thereafter until either oral treprostinil was commercially available to treat PH associated with HFpEF or the study was discontinued by the Sponsor. The Sponsor terminated Studies TDE-HF-301 and TDE-HF-302 on 14 October 2019 due to slow enrollment. Safety data from the final subject in Study TDE-HF-302 were recorded on 02 March 2020. Due to the lower than expected number of subjects enrolled, the planned secondary efficacy-related endpoints were not analyzed.
Study identification
- NCT ID
- NCT03043651
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 48 participants
Conditions and interventions
Conditions
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
- Jan 30, 2018 (Actual)
- Primary completion
- Mar 2, 2020 (Actual)
- Completion
- Mar 2, 2020 (Actual)
- Last update posted
- Oct 22, 2020
2018 – 2020
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 Heart and Vascular Hospital | 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 Toldedo 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 | 37232-2650 | — |
| 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 | 84143 | — |
| 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 NCT03043651, 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 Oct 22, 2020 · Synced Oct 23, 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 NCT03043651 live on ClinicalTrials.gov.