Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Drug: observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi
- Registration Number
- NCT01389206
- Lead Sponsor
- Actelion
- Brief Summary
Knowledge Translation Program for the guidelines and evidence-based management of PAH patients
- Detailed Description
To improve the management of PAH patients through an evidence-based approach aimed at achieving optimal WHO functional class (defined as: 1) improvement of FC III or IV to FC II; 2) improvement of FC II to FC I; or 3) maintaining FC II or I)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 797
-
Male and female adults (≥ 18 years of age)
-
Documented diagnosis of PAH (all of the following): i. RHC demonstrating mPAP > 25 mm Hg and PCWP
≤ 15 and PVR > 3 ii. FEV 1 > 50% predicted normal iii. V/Q and/or CT scan excluding the thromboembolic etiology
-
Diagnosis of PAH < 3 years
-
Need for PAH specific treatment
-
Desire to participate and signs an informed consent
Any of the criteria below:
- Poor mental function, drug or substance (e.g.,alcohol) abuse, or unstable psychiatric illness, which, in the opinion of the investigator, may interfere with optimal participation in the study
- Prior participation in this program
- Patients with pulmonary hypertension classified as group 2 - 5 Updated Clinical Classification of Pulmonary Hypertension (5th World Symposium on PH Modified Classification of PH)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Standard of care observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi Observational study to improve the management of PAH patients through an evidence-based approach aimed at achieving optimal WHO functional class (FC) treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi.
- Primary Outcome Measures
Name Time Method Patients achieving guideline-recommended treatment 3 years Proportion of patients achieving guideline-recommended treatment
- Secondary Outcome Measures
Name Time Method Patients achieving optimal functional class 3 years Proportion of patients achieving optimal functional class using an evidence-based treatment algorithm
Trial Locations
- Locations (76)
UT Health - University of Texas Houston
🇺🇸Houston, Texas, United States
University of South Alabama Medical Center
🇺🇸Mobile, Alabama, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Alliance Medical and Research Center
🇺🇸Fountain Valley, California, United States
Paloma Medical Group
🇺🇸San Juan Capistrano, California, United States
Scripps Clinic, Scripps Green Hospital
🇺🇸La Jolla, California, United States
Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
South Denver Cardiology Associates PC
🇺🇸Littleton, Colorado, United States
Robert E. Benkert, M.D.P.C.
🇺🇸Wheat Ridge, Colorado, United States
Lung Health & Sleep Enhancement Center, LLC
🇺🇸Newark, Delaware, United States
Bay Area Cardiology Research, P.A.
🇺🇸Brandon, Florida, United States
Bay Area Chest Physicians
🇺🇸Clearwater, Florida, United States
Broward Pulmonary and Sleep Specialists
🇺🇸Fort Lauderdale, Florida, United States
Pulmonary Diseases, Internal Medicine, Critical Care Medicine
🇺🇸Fort Lauderdale, Florida, United States
Mount Sinai Medical Centre - Columbia University - Division of Cardiology
🇺🇸Miami Beach, Florida, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
Lung Associates of Sarasota
🇺🇸Sarasota, Florida, United States
Unity Point Health Pulmonary Services
🇺🇸Peoria, Illinois, United States
University of Iowa Hospitals & Clinics
🇺🇸Iowa City, Iowa, United States
Kentuckiana Pulmonary Associates
🇺🇸Louisville, Kentucky, United States
University of Louisville School of Medicine
🇺🇸Louisville, Kentucky, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
University of Michigan Pulmonary Hypertension Program
🇺🇸Ann Arbor, Michigan, United States
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
William Beaumont Hospital - Troy
🇺🇸Troy, Michigan, United States
Nebraska Pulmonary Specialties, LLC
🇺🇸Lincoln, Nebraska, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Michael Schwarz, MDFACC
🇺🇸Bloomfield, New Jersey, United States
Pulmonary Hypertension & Lung Transplant Program Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Respiratory Health & Critical Care Associates
🇺🇸Hawthorne, New Jersey, United States
North Shore - LIJ Health System
🇺🇸New Hyde Park, New York, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
Wake Forest University Phyisicans Clinic/Pulmonary
🇺🇸Winston-Salem, North Carolina, United States
University of Toledo Health Sciences Campus
🇺🇸Toledo, Ohio, United States
Central Bucks Specialists - The Pavilion at Doylestown Hospital
🇺🇸Doylestown, Pennsylvania, United States
Dayton Respiratory Center
🇺🇸Dayton, Ohio, United States
Heart Center Cardiology
🇺🇸Bend, Oregon, United States
Institute for Respiratory and Sleep Medicine
🇺🇸Langhorne, Pennsylvania, United States
Respiratory Specialists
🇺🇸Wyomissing, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Wellspan Lung, Sleep and Critical Care
🇺🇸York, Pennsylvania, United States
Statcare Pulmonary Consultants
🇺🇸Knoxville, Tennessee, United States
Sioux Falls Cardiovascular PC
🇺🇸Sioux Falls, South Dakota, United States
El Paso Respiratory and Sleep Consultants
🇺🇸El Paso, Texas, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Providence Health Center
🇺🇸Waco, Texas, United States
IHVI, Advanced Lung Disease and Transplant Clinic
🇺🇸Falls Church, Virginia, United States
Sentara Medical Group
🇺🇸Norfolk, Virginia, United States
PAH Clinic CPR at Auxilio Mutuo
🇵🇷San Juan, Puerto Rico
University of Southern California
🇺🇸Los Angeles, California, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
University of Maryland Medical Centre
🇺🇸Baltimore, Maryland, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Pulmonary Hypertension Program, Cardiology, Children's Hospial of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Cardiac Study Center
🇺🇸Puyallup, Washington, United States
Pulmonary Vascular Disease Program, Penn Presbyterian Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
University of Cincinnati Pulmonary Critical Care & Sleep Medicine
🇺🇸Cincinnati, Ohio, United States
The Lung Center of Nevada
🇺🇸Las Vegas, Nevada, United States
The Christ Hospital Heart & Vascular Center
🇺🇸Cincinnati, Ohio, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Cardiovascular Associates, PC
🇺🇸Birmingham, Alabama, United States
Pulmonary Associates
🇺🇸Phoenix, Arizona, United States
Wayne State University, Detroit Medical Center
🇺🇸Detroit, Michigan, United States
Creighton University Medical Centre - Pulmonary, Critical Care and Sleep Medicine Division
🇺🇸Omaha, Nebraska, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Central Florida Pulmonary Group, PA
🇺🇸Orlando, Florida, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States