Tyvaso Dosing and Titration Evaluation: TyTRATE Registry
A Patient Registry to Observe the Real-World Dosing and Titration of Tyvaso®
1 other identifier
observational
98
2 countries
52
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2013
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 12, 2013
CompletedFirst Posted
Study publicly available on registry
February 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMarch 24, 2015
May 1, 2014
1.9 years
February 12, 2013
March 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Observe dose changes of Tyvaso over time
6 Months
Eligibility Criteria
Patients newly initiating on Tyvaso therapy for the treatment of PAH
You may qualify if:
- 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.
You may not qualify if:
- Have previously received Tyvaso.
- Are currently enrolled in an interventional (non-FDA approved) PH clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
The Regents of the University of California
La Jolla, California, 92037, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
Southern California Permanente
Pasadena, California, 91101, United States
Central Coast Chest Consultants
San Luis Obispo, California, 93401, United States
Pacific Sleep Disorders Center
Stockton, California, 95210, United States
Prime Healthcare, PC
West Hartford, Connecticut, 06107, United States
Bay Area Cardiology Associates, PA
Brandon, Florida, 33511, United States
Florida Lung & Sleep Specialist
Celebration, Florida, 32747, United States
Unknown Facility
Jacksonville, Florida, 32216, United States
Sacred Heart Medical Group
Miramar Beach, Florida, 32550, United States
Cardiology Consultants
Pensacola, Florida, 32501, United States
Pensacola Lung Group
Pensacola, Florida, 32504, United States
Sacred Heart Medical Group
Pensacola, Florida, 32504, United States
Pediatrix Cardiology Associates
Tampa, Florida, 33607, United States
Doctors Hospital of Augusta
Augusta, Georgia, 30909, United States
On Site Clinical Solutions
Cumming, Georgia, 30041, United States
Duluth Biomedical Research
Duluth, Georgia, 30096, United States
Gwinnett Consultants in Cardiology
Lawrenceville, Georgia, 30046, United States
Atlanta Cardiology Consultants
Roswell, Georgia, 30076, United States
Queens Medical Center - Honolulu
‘Aiea, Hawaii, 97601, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Dor Heart and Vascular Clinic
Gurnee, Illinois, 60031, United States
Loyola University of Chicago
Maywood, Illinois, 60153, United States
Advocate Medical Group
Oak Brook, Illinois, 60523, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
Clarian Health Methodist Hospital
Indianapolis, Indiana, 46202, United States
MedStar Health Institute
Hyattsville, Maryland, 20782, United States
Pulmonary and Care Associates of Baltimore
Pikesville, Maryland, 21117, United States
Madison Medical Affiliates
Milwaukee, Michigan, 53212, United States
Singing River Health System
Pascagoula, Mississippi, 39581, United States
AZ Perfection Clinical
Union, New Jersey, 07083, United States
Presbyterian Heart Group
Albuquerque, New Mexico, 87106, United States
Heart and Lung Associates, PC
Bayside, New York, 11361, United States
New York Methodist Hospital
Brooklyn, New York, 11215, United States
Asheville Cardiology Associates
Asheville, North Carolina, 28803, United States
Sanford Heart Hospital
Fargo, North Dakota, 58122, United States
Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Midwest Pulmonary & Sleep Research
Dayton, Ohio, 45459, United States
Southwest General Health Center
Middleburg Heights, Ohio, 44130, United States
INTEGRIS Baptist Medical Center, Inc
Oklahoma City, Oklahoma, 73112, United States
The Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096, United States
WellSpan Health
York, Pennsylvania, 17405, United States
Maury Regional Medical Center
Columbia, Tennessee, 20910, United States
Pulmonary Consultants of San Antonio, PA
San Antonio, Texas, 78229, United States
The Rector and Visitors of the University of Virginia
Charlottesville, Virginia, 22903, United States
Carilion Medical Center
Roanoke, Virginia, 24014, United States
Pulmonary & Sleep Research
Spokane, Washington, 99204, United States
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53705, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
The Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, 53226, United States
CardioPulmonary Research Center
Guaynabo, 00968, Puerto Rico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2013
First Posted
February 26, 2013
Study Start
January 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
March 24, 2015
Record last verified: 2014-05