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

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 797

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients achieving guideline-recommended treatment	Proportion of patients achieving guideline-recommended treatment	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients achieving optimal functional class	Proportion of patients achieving optimal functional class using an evidence-based treatment algorithm	3 years

Collaborators and Investigators

• Sponsor: Actelion
• Collaborators: Canadian Heart Research Centre
• Investigators: Study Chair: Vallerie McLaughlin, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): April 10, 2018
• Study Completion (Actual): April 10, 2018

Study Registration Dates

• First Submitted: July 6, 2011
• First Submitted That Met QC Criteria: July 7, 2011
• First Posted (Estimate): July 8, 2011

Study Record Updates

• Last Update Posted (Actual): August 15, 2018
• Last Update Submitted That Met QC Criteria: August 14, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Platelet Aggregation Inhibitors; Endothelin Receptor Antagonists; Endothelin A Receptor Antagonists; Endothelin B Receptor Antagonists; Iloprost; Bosentan; Macitentan; Selexipag
• Other Study ID Numbers: AC-052-428

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No