Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program (PAH QuERI Ext)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment
Pulmonary Arterial Hypertension	Drug: observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi

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)

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational [Patient Registry]
Actual Enrollment :	797 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Target Follow-Up Duration:	3 Years
Official Title:	Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program
Study Start Date :	June 1, 2011
Estimated Primary Completion Date :	June 30, 2018
Estimated Study Completion Date :	June 30, 2018

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
Standard of care; 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.	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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Patients achieving guideline-recommended treatment [ Time Frame: 3 years ]
   Proportion of patients achieving guideline-recommended treatment

Secondary Outcome Measures :

1. Patients achieving optimal functional class [ Time Frame: 3 years ]
   Proportion of patients achieving optimal functional class using an evidence-based treatment algorithm

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Approximately 800 PAH patients from approximately 80 physician practices will be included in the program.

Criteria

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)

Contacts and Locations

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Locations

United States, Alabama
Cardiovascular Associates, PC
Birmingham, Alabama, United States, 35216
University of South Alabama Medical Center
Mobile, Alabama, United States, 36617
United States, Arizona
Pulmonary Associates
Phoenix, Arizona, United States, 85006
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Alliance Medical and Research Center
Fountain Valley, California, United States, 92866
Scripps Clinic, Scripps Green Hospital
La Jolla, California, United States, 92037
University of Southern California
Los Angeles, California, United States, 90033
Paloma Medical Group
San Juan Capistrano, California, United States, 92675
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
South Denver Cardiology Associates PC
Littleton, Colorado, United States, 80120
Robert E. Benkert, M.D.P.C.
Wheat Ridge, Colorado, United States, 80033
United States, Delaware
Lung Health & Sleep Enhancement Center, LLC
Newark, Delaware, United States, 19713
United States, Florida
Bay Area Cardiology Research, P.A.
Brandon, Florida, United States, 33511
Bay Area Chest Physicians
Clearwater, Florida, United States, 33756
Broward Pulmonary and Sleep Specialists
Fort Lauderdale, Florida, United States, 33316
Pulmonary Diseases, Internal Medicine, Critical Care Medicine
Fort Lauderdale, Florida, United States, 33334
Mount Sinai Medical Centre - Columbia University - Division of Cardiology
Miami Beach, Florida, United States, 33140
Central Florida Pulmonary Group, PA
Orlando, Florida, United States, 32803
Lung Associates of Sarasota
Sarasota, Florida, United States, 34239
Cleveland Clinic Florida
Weston, Florida, United States, 33331
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Unity Point Health Pulmonary Services
Peoria, Illinois, United States, 61602
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52301
United States, Kentucky
Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States, 40202
University of Louisville School of Medicine
Louisville, Kentucky, United States, 40202
United States, Louisiana
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Maryland
University of Maryland Medical Centre
Baltimore, Maryland, United States, 21201
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Michigan
University of Michigan Pulmonary Hypertension Program
Ann Arbor, Michigan, United States, 48109
Wayne State University, Detroit Medical Center
Detroit, Michigan, United States, 48324
Spectrum Health
Grand Rapids, Michigan, United States, 49525
William Beaumont Hospital - Troy
Troy, Michigan, United States, 48085
United States, Nebraska
Nebraska Pulmonary Specialties, LLC
Lincoln, Nebraska, United States, 68506
Creighton University Medical Centre - Pulmonary, Critical Care and Sleep Medicine Division
Omaha, Nebraska, United States, 68131
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-5300
United States, Nevada
The Lung Center of Nevada
Las Vegas, Nevada, United States, 89128
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0001
United States, New Jersey
Michael Schwarz, MDFACC
Bloomfield, New Jersey, United States, 07003
Respiratory Health & Critical Care Associates
Hawthorne, New Jersey, United States, 07506
Pulmonary Hypertension & Lung Transplant Program Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
United States, New York
North Shore - LIJ Health System
New Hyde Park, New York, United States, 11040
Beth Israel Medical Center
New York, New York, United States, 10003
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
East Carolina University
Greenville, North Carolina, United States, 27834
Wake Forest University Phyisicans Clinic/Pulmonary
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
The Christ Hospital Heart & Vascular Center
Cincinnati, Ohio, United States, 45219
University of Cincinnati Pulmonary Critical Care & Sleep Medicine
Cincinnati, Ohio, United States, 45219
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Dayton Respiratory Center
Dayton, Ohio, United States, 45215
University of Toledo Health Sciences Campus
Toledo, Ohio, United States, 43614
United States, Oregon
Heart Center Cardiology
Bend, Oregon, United States, 97701
United States, Pennsylvania
Central Bucks Specialists - The Pavilion at Doylestown Hospital
Doylestown, Pennsylvania, United States, 18901
Institute for Respiratory and Sleep Medicine
Langhorne, Pennsylvania, United States, 19007
Pulmonary Hypertension Program, Cardiology, Children's Hospial of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Pulmonary Vascular Disease Program, Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Respiratory Specialists
Wyomissing, Pennsylvania, United States, 19610
Wellspan Lung, Sleep and Critical Care
York, Pennsylvania, United States, 17402
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, South Dakota
Sioux Falls Cardiovascular PC
Sioux Falls, South Dakota, United States, 57103
United States, Tennessee
Statcare Pulmonary Consultants
Knoxville, Tennessee, United States, 37919
United States, Texas
El Paso Respiratory and Sleep Consultants
El Paso, Texas, United States, 79902
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Baylor College of Medicine
Houston, Texas, United States, 77030
UT Health - University of Texas Houston
Houston, Texas, United States, 77030
Providence Health Center
Waco, Texas, United States, 76712
United States, Virginia
IHVI, Advanced Lung Disease and Transplant Clinic
Falls Church, Virginia, United States, 22042
Sentara Medical Group
Norfolk, Virginia, United States, 23507
United States, Washington
Cardiac Study Center
Puyallup, Washington, United States, 98372
Puerto Rico
PAH Clinic CPR at Auxilio Mutuo
San Juan, Puerto Rico, 00918

Sponsors and Collaborators

Actelion

Canadian Heart Research Centre

Investigators

Study Chair:	Vallerie McLaughlin, MD	University of Michigan

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Actelion
ClinicalTrials.gov Identifier:	NCT01389206 History of Changes
Other Study ID Numbers:	AC-052-428
First Posted:	July 8, 2011
Last Update Posted:	March 12, 2018
Last Verified:	March 2018

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:

Hypertension; Familial Primary Pulmonary Hypertension; Vascular Diseases; Cardiovascular Diseases; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Iloprost; Tezosentan; Bosentan	Selexipag; Macitentan; Platelet Aggregation Inhibitors; Vasodilator Agents; Antihypertensive Agents; Endothelin Receptor Antagonists; Molecular Mechanisms of Pharmacological Action; Endothelin A Receptor Antagonists; Endothelin B Receptor Antagonists