A Registry for Patients Taking Uptravi
- Conditions
- Pulmonary Arterial Hypertension
- Registration Number
- NCT03278002
- Lead Sponsor
- Actelion
- Brief Summary
This is a US multi-center, prospective, real world, observational drug registry enrolling patients actively treated with Uptravi. Participating patients will be followed prospectively for a maximum of 18 months from the date of enrollment into the registry.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 800
-
Signed patient informed consent form (ICF).
-
Patients ≥ 18 years of age at time of Uptravi initiation, and
-
Patients who initiate Uptravi:
- at enrollment, or
- less than or equal to 60 days prior to enrollment and have a documented titration regimen (defined as all documented dose changes including, but not limited to: starting dose and dates and highest tolerated dose and dates)
- Patients previously exposed to Uptravi treatment during a clinical trial.
- Patients that previously discontinued Uptravi for any reason, prior to study enrollment (discontinuation defined as an interruption of therapy greater than or equal to 30 days).
- Patients enrolled in a blinded clinical trial or in a clinical trial involving an unapproved drug.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Using Electronic Medical Records, the change in Hemodynamics (by Right Heart Catherization), WHO FC and 6 Minute Walk Distance (by meters) from diagnosis to registry enrollment and to EOS will be measured/collected. Followed prospectively for a maximum of 18 months from the date of enrollment into the registry. To describe demographics and disease characteristics of patients treated with Uptravi.
The initial dose (in micrograms), dose at selected intervals (in days), highest dose, maintenance dose, time between titrations, time from initiation to maintenance dose (in days) and total duration of exposure to Uptravi (in days) will be collected. Followed prospectively for a maximum of 18 months from the date of enrollment into the registry. To describe the dosing regimens and titration of Uptravi, including any transition from other PAH specific therapies to Uptravi and from Uptravi to other prostanoids.
Occurrence of AEs and SAEs (incl. hospitalizations), discontinuation of Uptravi and reason for stopping and occurrence of all-cause death by relationship to PAH. Followed prospectively for a maximum of 18 months from the date of enrollment into the registry. To describe the clinical course of patients treated with Uptravi.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (85)
University of South Alabama
🇺🇸Mobile, Alabama, United States
University of Arizona-Clinical Translational and Regenerative Medicine
🇺🇸Tucson, Arizona, United States
Santa Barbara Cottage Hospital
🇺🇸Santa Barbara, California, United States
Florida Lung Asthma and Sleep Specialists
🇺🇸Celebration, Florida, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA
🇺🇸Torrance, California, United States
Banner Health Research Institute
🇺🇸Greeley, Colorado, United States
Broward Pulmonary and Sleep
🇺🇸Fort Lauderdale, Florida, United States
West Pasco Pulmonary Associates
🇺🇸Hudson, Florida, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
University of Florida-Jacksonville College of Medicine
🇺🇸Jacksonville, Florida, United States
Wellstar Marietta Pulmonary Medicine
🇺🇸Marietta, Georgia, United States
CIC Associates
🇺🇸Clive, Iowa, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Sparrow Clinical Research Institute
🇺🇸Lansing, Michigan, United States
Chest Medicine Associates
🇺🇸South Portland, Maine, United States
William Beaumont Hospital
🇺🇸Troy, Michigan, United States
Mercy Research, Mercy Hospital Saint Louis
🇺🇸Saint Louis, Missouri, United States
Somnos Clinical Research
🇺🇸Lincoln, Nebraska, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Pulmonary Health Physicians, PC
🇺🇸Fayetteville, New York, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Northwell Health
🇺🇸New Hyde Park, New York, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Weil Cornell Medicine
🇺🇸New York, New York, United States
Southwest General Health Center
🇺🇸Middleburg Heights, Ohio, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Doylestown Health Cardiology
🇺🇸Doylestown, Pennsylvania, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
York Hospital
🇺🇸York, Pennsylvania, United States
AnMed Health Medical Center
🇺🇸Anderson, South Carolina, United States
Baylor Scott and White Health
🇺🇸Dallas, Texas, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Sentara Cardiovascular Research Institute
🇺🇸Norfolk, Virginia, United States
Inova Fairfax
🇺🇸Falls Church, Virginia, United States
Providence Health & Services d/b/a/ Providence Sacred Heart Medical Center & Children's Hospital Providence Medical Research Center
🇺🇸Spokane, Washington, United States
Multicare Institute for Research & Innovation
🇺🇸Tacoma, Washington, United States
CardioPulmonary Research, PSC
🇵🇷Guaynabo, Puerto Rico
University of Southern California
🇺🇸Los Angeles, California, United States
VA Greater Los Angeles Healthcare Center
🇺🇸Los Angeles, California, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
University of Chicago Hospitals
🇺🇸Chicago, Illinois, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Tufts University Medical Center
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Pittsburgh School of Medicine
🇺🇸Pittsburgh, Pennsylvania, United States
Indiana University Health
🇺🇸Indianapolis, Indiana, United States
St. Vincent Medical Group, Inc.
🇺🇸Indianapolis, Indiana, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
University of Texas, Houston Health Center
🇺🇸Houston, Texas, United States
The Lindner Research Center at The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Methodist Healthcare of San Antonio
🇺🇸San Antonio, Texas, United States
UCSF Medical Center
🇺🇸San Francisco, California, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Pulmonary Associates
🇺🇸Phoenix, Arizona, United States
Cardioivascular Consultants, Ltd.
🇺🇸Phoenix, Arizona, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Legacy Medical Group-Pulmonary and Sleep Clinic
🇺🇸Portland, Oregon, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Medical College of Wisconsin/Froedtert Hospital
🇺🇸Milwaukee, Wisconsin, United States
Aurora Research Institute / Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
Norton Pulmonary Specialists
🇺🇸Louisville, Kentucky, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
University of Florida, HSC
🇺🇸Gainesville, Florida, United States
Central Florida Pulmonary Group
🇺🇸Orlando, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Oschner Clinic Foundation/Oschner Medical Center
🇺🇸New Orleans, Louisiana, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
University of North Carolina Hospitals at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Wisconsin School of Medicine and Public Health
🇺🇸Madison, Wisconsin, United States
University of California San Diego
🇺🇸La Jolla, California, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States