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

This study is currently recruiting participants.
Verified May 2013 by Actelion
Sponsor:
Collaborator:
Canadian Heart Research Centre
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01389206
First received: July 6, 2011
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

This program intends to improve the management of pulmonary arterial hypertension (PAH) patients through an evidence-based approach aimed at achieving optimal World Health Organization (WHO) functional class (FC): 1. Improving FC III & IV patients to FC II, 2. Improving FC II patients to FC I, and 3. Maintaining FC II & FC I patients.


Condition
Pulmonary Arterial Hypertension

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pulmonary Arterial Hypertension (PAH) Quality Enhancement Research Initiative (QuERI) Extension Program

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Patients achieving guideline-recommended treatment [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Proportion of patients achieving guideline-recommended treatment


Secondary Outcome Measures:
  • Patients achieving optimal functional class [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Proportion of patients achieving optimal functional class using an evidence-based treatment algorithm


Estimated Enrollment: 800
Study Start Date: June 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Standard of care
Patients with pulmonary arterial hypertension

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Physician practices

Criteria

Inclusion Criteria:

  1. Male and female adults (>/= 18 years of age)
  2. Documented diagnosis of pulmonary arterial hypertension (PAH) (all of the following):

    i. Right Heart Catheterization (RHC) demonstrating mean Pulmonary Arterial Pressure (mPAP) > 25mm Hg and Pulmonary Capillary Wedge Pressure (PCWP) ii. Forced Expiratory Volume in the first second (FEV1) > 50% predicted normal iii. Ventilation/Perfusion (V/Q) and/or Computerized Tomography (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:

  • 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; c. Patients with pulmonary hypertension classified as group 2 - 5 Dana Point, 2008 updated clinical classification.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01389206

  Hide Study Locations
Locations
United States, Alabama
Cardiovascular Associates, PC Recruiting
Birmingham, Alabama, United States, 35216
Contact: Barry Rayburn    205-599-3500    brayburn@cvapc.com   
Principal Investigator: Barry Rayburn, MD         
University of South Alabama Medical Center Recruiting
Mobile, Alabama, United States, 36617
Contact: Karen Fagan    251-471-7291    kfagan@usouthal.edu   
Principal Investigator: Karen Fagan, MD         
United States, Arizona
Pulmonary Associates Recruiting
Phoenix, Arizona, United States, 85006
Contact: David Baratz, MD    602-258-4951    dbaratz@aol.com   
Principal Investigator: David Baratz, MD         
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Larry G Johnson    501-686-5525    LGJohnson@uams.edu   
Principal Investigator: Larry G Johnson, MD         
United States, California
Alta Bates Summit Medical Center Recruiting
Berkeley, California, United States, 94705
Contact: Luisa Munoz del Romeral    510-204-2009    munozl@bcvmg.com   
Principal Investigator: Luisa Munoz, MD         
Alliance Medical and Research Center Recruiting
Fountain Valley, California, United States, 92866
Contact: David Pham, MD    714-887-0400    david_phammd@yahoo.com   
Principal Investigator: David Pham, MD         
Scripps Clinic, Scripps Green Hospital Not yet recruiting
La Jolla, California, United States, 92037
Contact: Ashley Clare    858-554-5588    clare.ashley@scrippshealth.org   
Principal Investigator: J. Thomas Heywood, MD         
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Sivagini Ganesh    323-442-6077    sivaging@usc.edu   
Principal Investigator: Sivagini Ganesh, MD         
Paloma Medical Group Recruiting
San Juan Capistrano, California, United States, 92675
Contact: Michael Rovzar, MD    949-291-6521    rovzar.mike@cogenthealthcare.com   
Principal Investigator: Michael Rovzar, MD         
Harbor-UCLA Medical Center Recruiting
Torrance, California, United States, 90502
Contact: Ronald Oudiz    310-222-5152 ext 515    roudiz@labiomed.org   
Principal Investigator: Ronald Oudiz, MD         
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: David Badesch    720-848-6567    David.Badesch@ucdenver.edu   
Principal Investigator: David Badesch, MD         
South Denver Cardiology Associates PC Recruiting
Littleton, Colorado, United States, 80120
Contact: Ira Dauber    303-715-2210    irad@southdenver.com   
Principal Investigator: Ira Dauber, MD         
Robert E. Benkert, M.D.P.C. Recruiting
Wheatridge, Colorado, United States, 80033
Contact: Robert Benkert, M.D.P.C.    303-821-6922    lrrebenkert@comcast.net   
Principal Investigator: Robert Benkert, MD         
United States, Delaware
Lung Health & Sleep Enhancement Center, LLC Recruiting
Newark, Delaware, United States, 19713
Contact: Gerald O'Brien    302-368-5515 ext 104    gobrien@christianacare.org   
Principal Investigator: Gerald O'Brien, MD         
United States, District of Columbia
Georgetown University Hospital Not yet recruiting
Washington, District of Columbia, United States, 20007
Contact: Tunay Kuru, MD    202-444-5510    tk53@georgetown.edu   
Principal Investigator: Tunay Kuru, MD         
United States, Florida
Bay Area Cardiology Research, P.A. Recruiting
Brandon, Florida, United States, 33511
Contact: Robert Dewhurst    813-684-6000    rdewhurs@yahoo.com   
Principal Investigator: Robert Dewhurst, MD         
Bay Area Chest Physicians Recruiting
Clearwater, Florida, United States, 33756
Contact: Devendra Amin    727-443-0611    alveoli.dna@gmail.com   
Principal Investigator: Devendra Amin, MD         
Broward Pulmonary and Sleep Specialists Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Frank P Hull    954-522-7226    frankhull@yahoo.com   
Principal Investigator: Frank P Hull, MD         
Central Florida Pulmonary Group, PA Recruiting
Orlando, Florida, United States, 32803
Contact: Daniel Layish    407-448-6024    dlayish1@sprint.blackberry.net   
Principal Investigator: Daniel Layish, MD         
Lung Associates of Sarasota Recruiting
Sarasota, Florida, United States, 34239
Contact: Greg Ferreira, MD    941-366-5864    gferreira71@verizon.net   
Principal Investigator: Greg Ferreira, MD         
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
Contact: Franck Rahaghi    954-659-5450    rahaghf@ccf.org   
Principal Investigator: Franck Rahaghi, MD         
United States, Georgia
Piedmont Healthcare Not yet recruiting
Atlanta, Georgia, United States, 30309
Contact: Jeffrey Michaelson, MD    404-358-4112      
Principal Investigator: Jeffrey Michaelson, MD         
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Roberto Machado    312-355-5894    machador@uic.edu   
Principal Investigator: Roberto Machado, MD         
United States, Iowa
University of Iowa Hospitals & Clinics Recruiting
Iowa City, Iowa, United States, 52301
Contact: Sif Hansdottir    319-356-4215    sif-hansdottir@uiowa.edu   
Principal Investigator: Sif Hansdottir, MD         
United States, Kentucky
Kentuckiana Pulmonary Associates Recruiting
Louisville, Kentucky, United States, 40202
Contact: John W McConnell    502-587-8000    mcco3526@bellsouth.net   
Principal Investigator: John W McConnell, MD         
University of Louisville School of Medicine Not yet recruiting
Louisville, Kentucky, United States, 40202
Contact: Shaun Smith, MD    502-852-5841    Jshaun.smith@louisville.edu   
Principal Investigator: Shaun Smith, MD         
United States, Louisiana
Ochsner Medical Center Not yet recruiting
New Orleans, Louisiana, United States, 70121
Contact: Stacy Mandras    504-842-5638    smandras@ochsner.org   
Principal Investigator: Stacy Mandras, MD         
United States, Maine
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
Contact: M. Elizabeth Knauft    207-662-2770    knaufe@mmc.org   
Principal Investigator: M. Elizabeth Knauft, MD         
United States, Maryland
University of Maryland Medical Centre Recruiting
Baltimore, Maryland, United States, 21201
Contact: Myung Park    410-328-7260    mpark@medicine.umaryland.edu   
Principal Investigator: Myung Park, MD         
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Paul Hassoun, MD    410-614-6311    phassou1@jhmi.edu   
Principal Investigator: Paul Hassoun, MD         
United States, Michigan
University of Michigan Pulmonary Hypertension Program Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Scott Visovatti    734-936-5383    cvc-ph-research@med.umich.edu   
Principal Investigator: Scott Visovatti, MD         
Wayne State University, Detroit Medical Center Recruiting
Detroit, Michigan, United States, 48324
Contact: Ghulam Saydain    313-966-0320    gsaydain@med.wayne.edu   
Principal Investigator: Ghulam Saydain, MD         
Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49525
Contact: Jeff Wilt    616-486-5560    jeffwilt@yahoo.com   
Principal Investigator: Jeff Wilt, MD         
William Beaumont Hospital - Troy Recruiting
Troy, Michigan, United States, 48085
Contact: Samuel Allen    248-964-2693    Samuel.Allen@beaumont.edu   
Principal Investigator: Samuel Allen, MD         
United States, Nebraska
Nebraska Pulmonary Specialties, LLC Recruiting
Lincoln, Nebraska, United States, 68506
Contact: William Johnson    501-686-5525    billjlungs@hotmail.com   
Principal Investigator: William Johnson, MD         
Creighton University Medical Centre - Pulmonary, Critical Care and Sleep Medicine Division Recruiting
Omaha, Nebraska, United States, 68131
Contact: Tammy Wichman, MD    402-449-4486    tammywichman@creighton.edu   
Principal Investigator: Tammy Wichman, MD         
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-5300
Contact: Austin Thompson    402-559-9101    athompso@unmc.edu   
Principal Investigator: Austin Thompson, MD         
United States, Nevada
The Lung Center of Nevada Recruiting
Las Vegas, Nevada, United States, 89128
Contact: George Tu    702-869-0855    GTu@lctrnv.com   
Principal Investigator: George Tu, MD         
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756-0001
Contact: Edward Catherwood    603-650-3540    Edward.Catherwood@hitchcock.org   
Principal Investigator: Edward Catherwood, MD         
United States, New Jersey
Michael Schwarz, MDFACC Recruiting
Bloomfield, New Jersey, United States, 07003
Contact: Michael Schwarz    973-779-0019    cardiocms@yahoo.com   
Principal Investigator: Michael Schwarz, MD         
Pulmonary Hypertension & Lung Transplant Program Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
Contact: Christina Migliore    973-926-4430    cmigliore@sbhcs.com   
Principal Investigator: Christina Migliore, MD         
United States, New York
North Shore - LIJ Health System Recruiting
New Hyde Park, New York, United States, 11040
Contact: Arunabh Talwar    516-465-5400    arunabh@nshs.edu   
Principal Investigator: Arunabh Talwar, MD         
Beth Israel Medical Center Recruiting
New York, New York, United States, 10003
Contact: Roxana Sulica    212-844-8824    rsulica@chpnet.org   
Principal Investigator: Roxana Sulica, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Terry Fortin    919-668-0325    tapso001@mc.duke.edu   
Principal Investigator: Terry Fortin, MD         
East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Contact: Zia Rehman, MD    252-744-5888    rehmanz@ecu.edu   
Principal Investigator: Zia Rehman, MD         
Wake Forest University Phyisicans Clinic/Pulmonary Recruiting
Winston Salem, North Carolina, United States, 27157
Contact: Rodolfo Pascual    336-713-7500    rpascual@wfubmc.edu   
Principal Investigator: Rodolfo Pascual, MD         
United States, Ohio
University of Cincinnati Pulmonary Critical Care & Sleep Medicine Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Jean Marie Elwing    513-558-0478    jean.elwing@uc.edu   
Principal Investigator: Jean Elwing, MD         
The Christ Hospital Heart & Vascular Center Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Peter Engel    513-382-6600    puregold76@aol.com   
Principal Investigator: Peter Engel, MD         
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Robert Schilz    216-844-2897    robert.schilz@uhhospitals.org;rschilz@gmail.com   
Principal Investigator: Robert Schilz, MD         
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Omar Minai, MD    216-445-2610    minaio@ccf.org   
Principal Investigator: Omar Minai, MD         
Dayton Respiratory Center Recruiting
Dayton, Ohio, United States, 45215
Contact: Anuj Goyal, MD    937-312-9144    goyalas@pol.net   
Principal Investigator: Anuj Goyal, MD         
University of Toledo Health Sciences Campus Recruiting
Toledo, Ohio, United States, 43614
Contact: Bashar Kahaleh    419-383-4271    bashar.kahaleh@utoledo.edu   
Principal Investigator: Bashar Kahaleh, MD         
United States, Oregon
Heart Center Cardiology Recruiting
Bend, Oregon, United States, 97701
Contact: Michael Widmer, MD    541-633-2516    michael@heartcentercardiology.com   
Principal Investigator: Michael Widmer, MD         
United States, Pennsylvania
Central Bucks Specialists - The Pavilion at Doylestown Hospital Recruiting
Doylestown, Pennsylvania, United States, 18901
Contact: Renne Sangrigoli, MD    215-345-6050    rsangmd@aol.com   
Principal Investigator: Renne Sangrigoli, MD         
Institute for Respiratory and Sleep Medicine Recruiting
Langhorne, Pennsylvania, United States, 19007
Contact: Richard Shusterman, MD    215-757-1414    rshusterma@aol.com   
Principal Investigator: Richard Shusterman, MD         
Pulmonary Hypertension Program, Cardiology, Children's Hospial of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Brian Hanna    215-590-5248    hannab@email.chop.edu   
Principal Investigator: Brian Hanna, MD         
Temple University Hospital Not yet recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Sheila Weaver    215-707-9929    sheila.weaver@tuhs.temple.edu   
Principal Investigator: Sheila Weaver, MD         
Pulmonary Vascular Disease Program, Penn Presbyterian Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jason Fritz    215-662-8585    jason.fritz@uphs.upenn.edu   
Principal Investigator: Jason Fritz, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Michael Mathier    412-647-3429    mathierm@upmc.edu   
Principal Investigator: Michael Mathier, MD         
Respiratory Specialists Recruiting
Wyomissing, Pennsylvania, United States, 19610
Contact: Alec Platt, MD    610-685-5864      
Principal Investigator: Alec Platt, MD         
Wellspan Lung, Sleep and Critical Care Recruiting
York, Pennsylvania, United States, 17402
Contact: Dmitriy Zubkus    717-851-2465    dzubkus@wellspan.org   
Principal Investigator: Dmitriy Zubkus, MD         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: James Klinger    401-444-9097    jklinger@lifespan.org   
Principal Investigator: James Klinger, MD         
United States, South Dakota
Sioux Falls Cardiovascular PC Recruiting
Sious Falls, South Dakota, United States, 57103
Contact: Kevin Vaska, MD    605-274-6300    kjvaska@aol.com   
Principal Investigator: Kevin Vaska, MD         
United States, Tennessee
Statcare Pulmonary Consultants Recruiting
Knoxville, Tennessee, United States, 37919
Contact: John Swisher    865-588-8831    jswisher@comcast.net   
Principal Investigator: John Swisher, MD         
United States, Texas
El Paso Respiratory and Sleep Consultants Recruiting
El Paso, Texas, United States, 79902
Contact: Hernando Garcia, MD    915-217-6723    hgarcia@pol.net   
Principal Investigator: Hernando Garcia, MD         
University of Texas Medical Branch Not yet recruiting
Galveston, Texas, United States, 77555
Contact: Alex Duarte, MD    409-772-2436    aduarte@utmb.edu   
Principal Investigator: Alex Duarte, MD         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Adaani Frost    713-798-2400    frost@bcm.edu   
Principal Investigator: Adaani Frost, MD         
UT Health - University of Texas Houston Recruiting
Houston, Texas, United States, 77030
Contact: Bela Patel    713-500-6838    bela.patel@uth.tmc.edu   
Principal Investigator: Bela Patel, MD         
Providence Health Center Not yet recruiting
Waco, Texas, United States, 76712
Contact: Charles Shoultz    254-399-5400    cshoultzsr@wacocardiology.com   
Principal Investigator: Charles Shoultz, MD         
United States, Virginia
IHVI, Advanced Lung Disease and Transplant Clinic Recruiting
Falls Church, Virginia, United States, 22042
Contact: Oksana Shlobin    703-776-2256    oksana.shlobin@inova.org   
Principal Investigator: Oksana Shlobin, MD         
Sentara Medical Group Recruiting
Norfolk, Virginia, United States, 23507
Contact: Michael Eggert, MD    757-388-5990    msbe@aol.com   
Principal Investigator: Michael Eggert, MD         
United States, Washington
Cardiac Study Center Recruiting
Puyallup, Washington, United States, 98372
Contact: Vinay Malhotra    253-572-7320    kathymarks@cardiacstudycenter.com   
Principal Investigator: Vinay Malhotra, MD         
Puerto Rico
PAH Clinic CPR at Auxilio Mutuo Recruiting
San Juan, Puerto Rico, 00918
Contact: Amarilys Santiago    787-200-4545    elbarosita@hotmail.com   
Principal Investigator: Alvaro Aranda, MD         
Sponsors and Collaborators
Actelion
Canadian Heart Research Centre
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01389206     History of Changes
Other Study ID Numbers: AC-052-428
Study First Received: July 6, 2011
Last Updated: May 16, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 22, 2014