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:
Actelion
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
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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:
Genetics Home Reference related topics:
pulmonary arterial hypertension
MedlinePlus related topics:
High Blood Pressure
U.S. FDA Resources
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:
- Male and female adults (>/= 18 years of age)
-
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
- Diagnosis of PAH < 3 years
- Need for PAH specific treatment
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01389206
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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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Adaani Frost 713-798-2400 frost@bcm.edu | |
| Principal Investigator: Adaani Frost, 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 Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on March 03, 2015