Tyvaso Dosing and Titration Evaluation: TyTRATE Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01799473
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : March 24, 2015
Information provided by (Responsible Party):
United Therapeutics

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.

Condition or disease
Pulmonary Arterial Hypertension

Study Type : Observational [Patient Registry]
Actual Enrollment : 98 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: A Patient Registry to Observe the Real-World Dosing and Titration of Tyvaso®
Study Start Date : January 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Primary Outcome Measures :
  1. Observe dose changes of Tyvaso over time [ Time Frame: 6 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients newly initiating on Tyvaso therapy for the treatment of PAH

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01799473

  Hide Study Locations
United States, California
The Regents of the University of California
La Jolla, California, United States, 92037
UCLA Medical Center
Los Angeles, California, United States, 90095
Southern California Permanente
Pasadena, California, United States, 91101
Central Coast Chest Consultants
San Luis Obispo, California, United States, 93401
Pacific Sleep Disorders Center
Stockton, California, United States, 95210
United States, Connecticut
Prime Healthcare, PC
West Hartford, Connecticut, United States, 06107
United States, Florida
Bay Area Cardiology Associates, PA
Brandon, Florida, United States, 33511
Florida Lung & Sleep Specialist
Celebration, Florida, United States, 32747
Jacksonville, Florida, United States, 32216
Sacred Heart Medical Group
Miramar Beach, Florida, United States, 32550
Cardiology Consultants
Pensacola, Florida, United States, 32501
Pensacola Lung Group
Pensacola, Florida, United States, 32504
Sacred Heart Medical Group
Pensacola, Florida, United States, 32504
Pediatrix Cardiology Associates
Tampa, Florida, United States, 33607
United States, Georgia
Doctors Hospital of Augusta
Augusta, Georgia, United States, 30909
On Site Clinical Solutions
Cumming, Georgia, United States, 30041
Duluth Biomedical Research
Duluth, Georgia, United States, 30096
Gwinnett Consultants in Cardiology
Lawrenceville, Georgia, United States, 30046
Atlanta Cardiology Consultants
Roswell, Georgia, United States, 30076
United States, Hawaii
Queens Medical Center - Honolulu
Aiea, Hawaii, United States, 97601
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Dor Heart and Vascular Clinic
Gurnee, Illinois, United States, 60031
Loyola University of Chicago
Maywood, Illinois, United States, 60153
Advocate Medical Group
Oakbrook, Illinois, United States, 60523
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
United States, Indiana
Clarian Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
United States, Maryland
MedStar Health Institute
Hyattsville, Maryland, United States, 20782
Pulmonary and Care Associates of Baltimore
Pikesville, Maryland, United States, 21117
United States, Michigan
Madison Medical Affiliates
Milwaukee, Michigan, United States, 53212
United States, Mississippi
Singing River Health System
Pascagoula, Mississippi, United States, 39581
United States, New Jersey
AZ Perfection Clinical
Union, New Jersey, United States, 07083
United States, New Mexico
Presbyterian Heart Group
Albuquerque, New Mexico, United States, 87106
United States, New York
Heart and Lung Associates, PC
Bayside, New York, United States, 11361
New York Methodist Hospital
Brooklyn, New York, United States, 11215
United States, North Carolina
Asheville Cardiology Associates
Asheville, North Carolina, United States, 28803
United States, North Dakota
Sanford Heart Hospital
Fargo, North Dakota, United States, 58122
United States, Ohio
Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Midwest Pulmonary & Sleep Research
Dayton, Ohio, United States, 45459
Southwest General Health Center
Middleburg Heights, Ohio, United States, 44130
United States, Oklahoma
INTEGRIS Baptist Medical Center, Inc
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
The Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, United States, 19096
WellSpan Health
York, Pennsylvania, United States, 17405
United States, Tennessee
Maury Regional Medical Center
Columbia, Tennessee, United States, 20910
United States, Texas
Pulmonary Consultants of San Antonio, PA
San Antonio, Texas, United States, 78229
United States, Virginia
The Rector and Visitors of the University of Virginia
Charlottesville, Virginia, United States, 22903
Carilion Medical Center
Roanoke, Virginia, United States, 24014
United States, Washington
Pulmonary & Sleep Research
Spokane, Washington, United States, 99204
United States, Wisconsin
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States, 53705
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
The Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, United States, 53226
Puerto Rico
CardioPulmonary Research Center
Guaynabo, Puerto Rico, 00968
Sponsors and Collaborators
United Therapeutics

Responsible Party: United Therapeutics Identifier: NCT01799473     History of Changes
Other Study ID Numbers: RIN-PH-404
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: May 2014

Keywords provided by United Therapeutics:

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases