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NCT01389206 Clinical Trial

Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program

Pulmonary Arterial Hypertension Clinical Trial

— PAH QuERI Ext  

Official title:
Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01389206
Other study ID # AC-052-428
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2011
Est. completion date April 10, 2018

Study information
Verified date August 2018
Source Actelion
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Knowledge Translation Program for the guidelines and evidence-based management of PAH patients

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 information / eligibility
Status Completed
Enrollment 797
Est. completion date April 10, 2018
Est. primary completion date April 10, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Male and female adults (= 18 years of age)

2. 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

3. Diagnosis of PAH < 3 years

4. Need for PAH specific treatment

5. Desire to participate and signs an informed consent

Exclusion Criteria:

Any of the criteria below:

1. 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

2. Prior participation in this program

3. 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

Related Conditions & MeSH terms

Intervention

Drug:
• observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi
observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi

Locations
Country Name City State
Puerto Rico PAH Clinic CPR at Auxilio Mutuo San Juan
United States University of Michigan Pulmonary Hypertension Program Ann Arbor Michigan
United States University of Colorado Denver Aurora Colorado
United States Johns Hopkins University Baltimore Maryland
United States University of Maryland Medical Centre Baltimore Maryland
United States Heart Center Cardiology Bend Oregon
United States Cardiovascular Associates, PC Birmingham Alabama
United States Michael Schwarz, MDFACC Bloomfield New Jersey
United States Bay Area Cardiology Research, P.A. Brandon Florida
United States Medical University of South Carolina Charleston South Carolina
United States University of Illinois at Chicago Chicago Illinois
United States The Christ Hospital Heart & Vascular Center Cincinnati Ohio
United States University of Cincinnati Pulmonary Critical Care & Sleep Medicine Cincinnati Ohio
United States Bay Area Chest Physicians Clearwater Florida
United States Cleveland Clinic Cleveland Ohio
United States University Hospitals Case Medical Center Cleveland Ohio
United States Dayton Respiratory Center Dayton Ohio
United States Wayne State University, Detroit Medical Center Detroit Michigan
United States Central Bucks Specialists - The Pavilion at Doylestown Hospital Doylestown Pennsylvania
United States Duke University Medical Center Durham North Carolina
United States El Paso Respiratory and Sleep Consultants El Paso Texas
United States IHVI, Advanced Lung Disease and Transplant Clinic Falls Church Virginia
United States Broward Pulmonary and Sleep Specialists Fort Lauderdale Florida
United States Pulmonary Diseases, Internal Medicine, Critical Care Medicine Fort Lauderdale Florida
United States Alliance Medical and Research Center Fountain Valley California
United States University of Texas Medical Branch Galveston Texas
United States Spectrum Health Grand Rapids Michigan
United States East Carolina University Greenville North Carolina
United States Respiratory Health & Critical Care Associates Hawthorne New Jersey
United States Baylor College of Medicine Houston Texas
United States UT Health - University of Texas Houston Houston Texas
United States Indiana University Indianapolis Indiana
United States University of Iowa Hospitals & Clinics Iowa City Iowa
United States Statcare Pulmonary Consultants Knoxville Tennessee
United States Scripps Clinic, Scripps Green Hospital La Jolla California
United States Institute for Respiratory and Sleep Medicine Langhorne Pennsylvania
United States The Lung Center of Nevada Las Vegas Nevada
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Nebraska Pulmonary Specialties, LLC Lincoln Nebraska
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States South Denver Cardiology Associates PC Littleton Colorado
United States University of Southern California Los Angeles California
United States Kentuckiana Pulmonary Associates Louisville Kentucky
United States University of Louisville School of Medicine Louisville Kentucky
United States Mount Sinai Medical Centre - Columbia University - Division of Cardiology Miami Beach Florida
United States University of South Alabama Medical Center Mobile Alabama
United States North Shore - LIJ Health System New Hyde Park New York
United States Ochsner Medical Center New Orleans Louisiana
United States Beth Israel Medical Center New York New York
United States Lung Health & Sleep Enhancement Center, LLC Newark Delaware
United States Pulmonary Hypertension & Lung Transplant Program Newark Beth Israel Medical Center Newark New Jersey
United States Sentara Medical Group Norfolk Virginia
United States Creighton University Medical Centre - Pulmonary, Critical Care and Sleep Medicine Division Omaha Nebraska
United States University of Nebraska Medical Center Omaha Nebraska
United States Central Florida Pulmonary Group, PA Orlando Florida
United States Unity Point Health Pulmonary Services Peoria Illinois
United States Pulmonary Hypertension Program, Cardiology, Children's Hospial of Philadelphia Philadelphia Pennsylvania
United States Pulmonary Vascular Disease Program, Penn Presbyterian Medical Center Philadelphia Pennsylvania
United States Temple University Hospital Philadelphia Pennsylvania
United States Pulmonary Associates Phoenix Arizona
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Maine Medical Center Portland Maine
United States Rhode Island Hospital Providence Rhode Island
United States Cardiac Study Center Puyallup Washington
United States Paloma Medical Group San Juan Capistrano California
United States Lung Associates of Sarasota Sarasota Florida
United States Sioux Falls Cardiovascular PC Sioux Falls South Dakota
United States University of Toledo Health Sciences Campus Toledo Ohio
United States Harbor-UCLA Medical Center Torrance California
United States William Beaumont Hospital - Troy Troy Michigan
United States Providence Health Center Waco Texas
United States Cleveland Clinic Florida Weston Florida
United States Robert E. Benkert, M.D.P.C. Wheat Ridge Colorado
United States Wake Forest University Phyisicans Clinic/Pulmonary Winston-Salem North Carolina
United States Respiratory Specialists Wyomissing Pennsylvania
United States Wellspan Lung, Sleep and Critical Care York Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Actelion Canadian Heart Research Centre

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patients achieving guideline-recommended treatment Proportion of patients achieving guideline-recommended treatment 3 years
Secondary Patients achieving optimal functional class Proportion of patients achieving optimal functional class using an evidence-based treatment algorithm 3 years
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