ClinicalTrials.gg
CompletedNCT01389206PAH QuERI ExtUpdated Aug 15, 2018

Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program

An observational study in Pulmonary Arterial Hypertension, sponsored by Actelion. Completed at 76 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-15.

Sponsored by Actelion (part of Johnson & Johnson) · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
797
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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)

02

Conditions studied

  • Pulmonary Arterial Hypertension
03

In context

Pulmonary Arterial Hypertension

773 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.

This study's enrollment of 797 is above the median of 100 across 201 observational studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

Actelion is the lead sponsor of 143 studies on the registry; 1 is open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 25 (89%) have results posted.

First submitted before Actelion became part of Johnson & Johnson.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
797 participants (actual)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • 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

Interventions

  • Drugobservational 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

06

What researchers measure

Primary outcomes

  1. Patients achieving guideline-recommended treatment

    Proportion of patients achieving guideline-recommended treatment

    Time frame: 3 years

Secondary outcomes

  1. Patients achieving optimal functional class

    Proportion of patients achieving optimal functional class using an evidence-based treatment algorithm

    Time frame: 3 years

07

Study locations

76 sites
  • Cardiovascular Associates, PC
    Birmingham, Alabama 35216, United States
  • University of South Alabama Medical Center
    Mobile, Alabama 36617, United States
  • Pulmonary Associates
    Phoenix, Arizona 85006, United States
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
  • Alliance Medical and Research Center
    Fountain Valley, California 92866, United States
  • Scripps Clinic, Scripps Green Hospital
    La Jolla, California 92037, United States
  • University of Southern California
    Los Angeles, California 90033, United States
  • Paloma Medical Group
    San Juan Capistrano, California 92675, United States
  • Harbor-UCLA Medical Center
    Torrance, California 90502, United States
  • University of Colorado Denver
    Aurora, Colorado 80045, United States
  • South Denver Cardiology Associates PC
    Littleton, Colorado 80120, United States
  • Robert E. Benkert, M.D.P.C.
    Wheat Ridge, Colorado 80033, United States
  • Lung Health & Sleep Enhancement Center, LLC
    Newark, Delaware 19713, United States
  • Bay Area Cardiology Research, P.A.
    Brandon, Florida 33511, United States
  • Bay Area Chest Physicians
    Clearwater, Florida 33756, United States
  • Broward Pulmonary and Sleep Specialists
    Fort Lauderdale, Florida 33316, United States
  • Pulmonary Diseases, Internal Medicine, Critical Care Medicine
    Fort Lauderdale, Florida 33334, United States
  • Mount Sinai Medical Centre - Columbia University - Division of Cardiology
    Miami Beach, Florida 33140, United States
  • Central Florida Pulmonary Group, PA
    Orlando, Florida 32803, United States
  • Lung Associates of Sarasota
    Sarasota, Florida 34239, United States
  • Cleveland Clinic Florida
    Weston, Florida 33331, United States
  • University of Illinois at Chicago
    Chicago, Illinois 60612, United States
  • Unity Point Health Pulmonary Services
    Peoria, Illinois 61602, United States
  • Indiana University
    Indianapolis, Indiana 46202, United States
  • University of Iowa Hospitals & Clinics
    Iowa City, Iowa 52301, United States
  • Kentuckiana Pulmonary Associates
    Louisville, Kentucky 40202, United States
  • University of Louisville School of Medicine
    Louisville, Kentucky 40202, United States
  • Ochsner Medical Center
    New Orleans, Louisiana 70121, United States
  • Maine Medical Center
    Portland, Maine 04102, United States
  • University of Maryland Medical Centre
    Baltimore, Maryland 21201, United States
  • Johns Hopkins University
    Baltimore, Maryland 21287, United States
  • University of Michigan Pulmonary Hypertension Program
    Ann Arbor, Michigan 48109, United States
  • Wayne State University, Detroit Medical Center
    Detroit, Michigan 48324, United States
  • Spectrum Health
    Grand Rapids, Michigan 49525, United States
  • William Beaumont Hospital - Troy
    Troy, Michigan 48085, United States
  • Nebraska Pulmonary Specialties, LLC
    Lincoln, Nebraska 68506, United States
  • Creighton University Medical Centre - Pulmonary, Critical Care and Sleep Medicine Division
    Omaha, Nebraska 68131, United States
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198-5300, United States
  • The Lung Center of Nevada
    Las Vegas, Nevada 89128, United States
  • Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire 03756-0001, United States
  • Michael Schwarz, MDFACC
    Bloomfield, New Jersey 07003, United States
  • Respiratory Health & Critical Care Associates
    Hawthorne, New Jersey 07506, United States
  • Pulmonary Hypertension & Lung Transplant Program Newark Beth Israel Medical Center
    Newark, New Jersey 07112, United States
  • North Shore - LIJ Health System
    New Hyde Park, New York 11040, United States
  • Beth Israel Medical Center
    New York, New York 10003, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • East Carolina University
    Greenville, North Carolina 27834, United States
  • Wake Forest University Phyisicans Clinic/Pulmonary
    Winston-Salem, North Carolina 27157, United States
  • The Christ Hospital Heart & Vascular Center
    Cincinnati, Ohio 45219, United States
  • University of Cincinnati Pulmonary Critical Care & Sleep Medicine
    Cincinnati, Ohio 45219, United States
  • University Hospitals Case Medical Center
    Cleveland, Ohio 44106, United States
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
  • Dayton Respiratory Center
    Dayton, Ohio 45215, United States
  • University of Toledo Health Sciences Campus
    Toledo, Ohio 43614, United States
  • Heart Center Cardiology
    Bend, Oregon 97701, United States
  • Central Bucks Specialists - The Pavilion at Doylestown Hospital
    Doylestown, Pennsylvania 18901, United States
  • Institute for Respiratory and Sleep Medicine
    Langhorne, Pennsylvania 19007, United States
  • Pulmonary Hypertension Program, Cardiology, Children's Hospial of Philadelphia
    Philadelphia, Pennsylvania 19104, United States
  • Pulmonary Vascular Disease Program, Penn Presbyterian Medical Center
    Philadelphia, Pennsylvania 19104, United States
  • Temple University Hospital
    Philadelphia, Pennsylvania 19140, United States
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania 15213, United States
  • Respiratory Specialists
    Wyomissing, Pennsylvania 19610, United States
  • Wellspan Lung, Sleep and Critical Care
    York, Pennsylvania 17402, United States
  • Rhode Island Hospital
    Providence, Rhode Island 02903, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • Sioux Falls Cardiovascular PC
    Sioux Falls, South Dakota 57103, United States
  • Statcare Pulmonary Consultants
    Knoxville, Tennessee 37919, United States
  • El Paso Respiratory and Sleep Consultants
    El Paso, Texas 79902, United States
  • University of Texas Medical Branch
    Galveston, Texas 77555, United States
  • Baylor College of Medicine
    Houston, Texas 77030, United States
  • UT Health - University of Texas Houston
    Houston, Texas 77030, United States
  • Providence Health Center
    Waco, Texas 76712, United States
  • IHVI, Advanced Lung Disease and Transplant Clinic
    Falls Church, Virginia 22042, United States
  • Sentara Medical Group
    Norfolk, Virginia 23507, United States
  • Cardiac Study Center
    Puyallup, Washington 98372, United States
  • PAH Clinic CPR at Auxilio Mutuo
    San Juan, 00918, Puerto Rico
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01389206
Lead sponsor
Actelion
Collaborators
Canadian Heart Research Centre
Responsible party
Sponsor
First posted
Jul 8, 2011
Start date
Jun 1, 2011
Primary completion
Apr 10, 2018
Completion
Apr 10, 2018
Last update
Aug 15, 2018

Study contacts

Vallerie McLaughlin, MD
study chair · University of Michigan

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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