Clinical trial NCT01799473: Tyvaso Dosing and Titration Evaluation: TyTRATE Registry
Official title: A Patient Registry to Observe the Real-World Dosing and Titration of Tyvaso®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Arterial Hypertension
Keywords: Tyvaso
PAH
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
First posted: 2013-02-26
Enrollment: 98
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients newly initiating on Tyvaso therapy for the treatment of PAH

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Observe dose changes of Tyvaso over time
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: The Regents of the University of California
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Pasadena
country: United States
facility: Southern California Permanente
state: California
city: San Luis Obispo
country: United States
facility: Central Coast Chest Consultants
state: California
city: Stockton
country: United States
facility: Pacific Sleep Disorders Center
state: California
city: West Hartford
country: United States
facility: Prime Healthcare, PC
state: Connecticut
city: Brandon
country: United States
facility: Bay Area Cardiology Associates, PA
state: Florida
city: Celebration
country: United States
facility: Florida Lung & Sleep Specialist
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miramar Beach
country: United States
facility: Sacred Heart Medical Group
state: Florida
city: Pensacola
country: United States
facility: Cardiology Consultants
state: Florida
city: Pensacola
country: United States
facility: Pensacola Lung Group
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Medical Group
state: Florida
city: Tampa
country: United States
facility: Pediatrix Cardiology Associates
state: Florida
city: Augusta
country: United States
facility: Doctors Hospital of Augusta
state: Georgia
city: Cumming
country: United States
facility: On Site Clinical Solutions
state: Georgia
city: Duluth
country: United States
facility: Duluth Biomedical Research
state: Georgia
city: Lawrenceville
country: United States
facility: Gwinnett Consultants in Cardiology
state: Georgia
city: Roswell
country: United States
facility: Atlanta Cardiology Consultants
state: Georgia
city: Aiea
country: United States
facility: Queens Medical Center - Honolulu
state: Hawaii
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Gurnee
country: United States
facility: Dor Heart and Vascular Clinic
state: Illinois
city: Maywood
country: United States
facility: Loyola University of Chicago
state: Illinois
city: Oakbrook
country: United States
facility: Advocate Medical Group
state: Illinois
city: Peoria
country: United States
facility: Methodist Medical Center of Illinois
state: Illinois
city: Indianapolis
country: United States
facility: Clarian Health Methodist Hospital
state: Indiana
city: Hyattsville
country: United States
facility: MedStar Health Institute
state: Maryland
city: Pikesville
country: United States
facility: Pulmonary and Care Associates of Baltimore
state: Maryland
city: Milwaukee
country: United States
facility: Madison Medical Affiliates
state: Michigan
city: Pascagoula
country: United States
facility: Singing River Health System
state: Mississippi
city: Union
country: United States
facility: AZ Perfection Clinical
state: New Jersey
city: Albuquerque
country: United States
facility: Presbyterian Heart Group
state: New Mexico
city: Bayside
country: United States
facility: Heart and Lung Associates, PC
state: New York
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: Asheville
country: United States
facility: Asheville Cardiology Associates
state: North Carolina
city: Fargo
country: United States
facility: Sanford Heart Hospital
state: North Dakota
city: Cincinnati
country: United States
facility: Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Dayton
country: United States
facility: Midwest Pulmonary & Sleep Research
state: Ohio
city: Middleburg Heights
country: United States
facility: Southwest General Health Center
state: Ohio
city: Oklahoma City
country: United States
facility: INTEGRIS Baptist Medical Center, Inc
state: Oklahoma
city: Wynnewood
country: United States
facility: The Lankenau Institute for Medical Research
state: Pennsylvania
city: York
country: United States
facility: WellSpan Health
state: Pennsylvania
city: Columbia
country: United States
facility: Maury Regional Medical Center
state: Tennessee
city: San Antonio
country: United States
facility: Pulmonary Consultants of San Antonio, PA
state: Texas
city: Charlottesville
country: United States
facility: The Rector and Visitors of the University of Virginia
state: Virginia
city: Roanoke
country: United States
facility: Carilion Medical Center
state: Virginia
city: Spokane
country: United States
facility: Pulmonary & Sleep Research
state: Washington
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: The Medical College of Wisconsin, Inc.
state: Wisconsin
city: Guaynabo
country: Puerto Rico
facility: CardioPulmonary Research Center
Study officials:
References: