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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014