Pulmonary Arterial Hypertension Clinical Trial
Official title:
A Patient Registry to Observe the Real-World Dosing and Titration of Tyvaso®
This prospective, observational, multi-center, patient registry will follow patients who are
newly initiated on Tyvaso for the treatment of Pulmonary Arterial Hypertension (PAH). Once
enrolled, the patients' dose and titration will be followed for the first 6 months of
treatment with Tyvaso.
A call-center will contact the patients directly at weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
to review their dose and titration schedule. In addition to patient-reported dosing data,
some patient demographic information, will be collected by the investigative site at
Baseline.
| Status | Completed |
| Enrollment | 98 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Are newly prescribed Tyvaso for the treatment of PAH and plan to initiate therapy - Are willing and able to be contacted by the patient call center. Exclusion Criteria: - Have previously received Tyvaso. - Are currently enrolled in an interventional (non-FDA approved) PH clinical trial. |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | CardioPulmonary Research Center | Guaynabo | |
| United States | Queens Medical Center - Honolulu | Aiea | Hawaii |
| United States | Presbyterian Heart Group | Albuquerque | New Mexico |
| United States | Asheville Cardiology Associates | Asheville | North Carolina |
| United States | Doctors Hospital of Augusta | Augusta | Georgia |
| United States | Heart and Lung Associates, PC | Bayside | New York |
| United States | Bay Area Cardiology Associates, PA | Brandon | Florida |
| United States | New York Methodist Hospital | Brooklyn | New York |
| United States | Florida Lung & Sleep Specialist | Celebration | Florida |
| United States | The Rector and Visitors of the University of Virginia | Charlottesville | Virginia |
| United States | Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois |
| United States | Children's Hospital Medical Center | Cincinnati | Ohio |
| United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | Maury Regional Medical Center | Columbia | Tennessee |
| United States | On Site Clinical Solutions | Cumming | Georgia |
| United States | Midwest Pulmonary & Sleep Research | Dayton | Ohio |
| United States | Duluth Biomedical Research | Duluth | Georgia |
| United States | Sanford Heart Hospital | Fargo | North Dakota |
| United States | Dor Heart and Vascular Clinic | Gurnee | Illinois |
| United States | MedStar Health Institute | Hyattsville | Maryland |
| United States | Clarian Health Methodist Hospital | Indianapolis | Indiana |
| United States | The Regents of the University of California | La Jolla | California |
| United States | Gwinnett Consultants in Cardiology | Lawrenceville | Georgia |
| United States | UCLA Medical Center | Los Angeles | California |
| United States | University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin |
| United States | Loyola University of Chicago | Maywood | Illinois |
| United States | Southwest General Health Center | Middleburg Heights | Ohio |
| United States | Madison Medical Affiliates | Milwaukee | Michigan |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | The Medical College of Wisconsin, Inc. | Milwaukee | Wisconsin |
| United States | Sacred Heart Medical Group | Miramar Beach | Florida |
| United States | Advocate Medical Group | Oakbrook | Illinois |
| United States | INTEGRIS Baptist Medical Center, Inc | Oklahoma City | Oklahoma |
| United States | Southern California Permanente | Pasadena | California |
| United States | Singing River Health System | Pascagoula | Mississippi |
| United States | Cardiology Consultants | Pensacola | Florida |
| United States | Pensacola Lung Group | Pensacola | Florida |
| United States | Sacred Heart Medical Group | Pensacola | Florida |
| United States | Methodist Medical Center of Illinois | Peoria | Illinois |
| United States | Pulmonary and Care Associates of Baltimore | Pikesville | Maryland |
| United States | Carilion Medical Center | Roanoke | Virginia |
| United States | Atlanta Cardiology Consultants | Roswell | Georgia |
| United States | Pulmonary Consultants of San Antonio, PA | San Antonio | Texas |
| United States | Central Coast Chest Consultants | San Luis Obispo | California |
| United States | Pulmonary & Sleep Research | Spokane | Washington |
| United States | Pacific Sleep Disorders Center | Stockton | California |
| United States | Pediatrix Cardiology Associates | Tampa | Florida |
| United States | AZ Perfection Clinical | Union | New Jersey |
| United States | Prime Healthcare, PC | West Hartford | Connecticut |
| United States | The Lankenau Institute for Medical Research | Wynnewood | Pennsylvania |
| United States | WellSpan Health | York | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| United Therapeutics |
United States, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Observe dose changes of Tyvaso over time | 6 Months | No |
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