Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program (PAH QuERI Ext)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01389206 |
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Recruitment Status :
Active, not recruiting
First Posted : July 8, 2011
Last Update Posted : March 12, 2018
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Sponsor:
Actelion
Collaborator:
Canadian Heart Research Centre
Information provided by (Responsible Party):
Actelion
- Study Details
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Brief Summary:
Knowledge Translation Program for the guidelines and evidence-based management of PAH patients
| Condition or disease | Intervention/treatment |
|---|---|
| Pulmonary Arterial Hypertension | Drug: observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi |
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 [Patient Registry] |
| Actual Enrollment : | 797 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 3 Years |
| Official Title: | Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program |
| Study Start Date : | June 1, 2011 |
| Estimated Primary Completion Date : | June 30, 2018 |
| Estimated Study Completion Date : | June 30, 2018 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Pulmonary arterial hypertension
| 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.
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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 |
Primary Outcome Measures :
- Patients achieving guideline-recommended treatment [ Time Frame: 3 years ]Proportion of patients achieving guideline-recommended treatment
Secondary Outcome Measures :
- Patients achieving optimal functional class [ Time Frame: 3 years ]Proportion of patients achieving optimal functional class using an evidence-based treatment algorithm
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | 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.
Criteria
Inclusion Criteria:
- Male and female adults (≥ 18 years of age)
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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
- 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
- Patients with pulmonary hypertension classified as group 2 - 5 Updated Clinical Classification of Pulmonary Hypertension (5th World Symposium on PH Modified Classification of PH)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01389206
Hide Study Locations
Locations
| United States, Alabama | |
| Cardiovascular Associates, PC | |
| Birmingham, Alabama, United States, 35216 | |
| University of South Alabama Medical Center | |
| Mobile, Alabama, United States, 36617 | |
| United States, Arizona | |
| Pulmonary Associates | |
| Phoenix, Arizona, United States, 85006 | |
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Alliance Medical and Research Center | |
| Fountain Valley, California, United States, 92866 | |
| Scripps Clinic, Scripps Green Hospital | |
| La Jolla, California, United States, 92037 | |
| University of Southern California | |
| Los Angeles, California, United States, 90033 | |
| Paloma Medical Group | |
| San Juan Capistrano, California, United States, 92675 | |
| Harbor-UCLA Medical Center | |
| Torrance, California, United States, 90502 | |
| United States, Colorado | |
| University of Colorado Denver | |
| Aurora, Colorado, United States, 80045 | |
| South Denver Cardiology Associates PC | |
| Littleton, Colorado, United States, 80120 | |
| Robert E. Benkert, M.D.P.C. | |
| Wheat Ridge, Colorado, United States, 80033 | |
| United States, Delaware | |
| Lung Health & Sleep Enhancement Center, LLC | |
| Newark, Delaware, United States, 19713 | |
| United States, Florida | |
| Bay Area Cardiology Research, P.A. | |
| Brandon, Florida, United States, 33511 | |
| Bay Area Chest Physicians | |
| Clearwater, Florida, United States, 33756 | |
| Broward Pulmonary and Sleep Specialists | |
| Fort Lauderdale, Florida, United States, 33316 | |
| Pulmonary Diseases, Internal Medicine, Critical Care Medicine | |
| Fort Lauderdale, Florida, United States, 33334 | |
| Mount Sinai Medical Centre - Columbia University - Division of Cardiology | |
| Miami Beach, Florida, United States, 33140 | |
| Central Florida Pulmonary Group, PA | |
| Orlando, Florida, United States, 32803 | |
| Lung Associates of Sarasota | |
| Sarasota, Florida, United States, 34239 | |
| Cleveland Clinic Florida | |
| Weston, Florida, United States, 33331 | |
| United States, Illinois | |
| University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612 | |
| Unity Point Health Pulmonary Services | |
| Peoria, Illinois, United States, 61602 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| University of Iowa Hospitals & Clinics | |
| Iowa City, Iowa, United States, 52301 | |
| United States, Kentucky | |
| Kentuckiana Pulmonary Associates | |
| Louisville, Kentucky, United States, 40202 | |
| University of Louisville School of Medicine | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Louisiana | |
| Ochsner Medical Center | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Maine | |
| Maine Medical Center | |
| Portland, Maine, United States, 04102 | |
| United States, Maryland | |
| University of Maryland Medical Centre | |
| Baltimore, Maryland, United States, 21201 | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Michigan | |
| University of Michigan Pulmonary Hypertension Program | |
| Ann Arbor, Michigan, United States, 48109 | |
| Wayne State University, Detroit Medical Center | |
| Detroit, Michigan, United States, 48324 | |
| Spectrum Health | |
| Grand Rapids, Michigan, United States, 49525 | |
| William Beaumont Hospital - Troy | |
| Troy, Michigan, United States, 48085 | |
| United States, Nebraska | |
| Nebraska Pulmonary Specialties, LLC | |
| Lincoln, Nebraska, United States, 68506 | |
| Creighton University Medical Centre - Pulmonary, Critical Care and Sleep Medicine Division | |
| Omaha, Nebraska, United States, 68131 | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-5300 | |
| United States, Nevada | |
| The Lung Center of Nevada | |
| Las Vegas, Nevada, United States, 89128 | |
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756-0001 | |
| United States, New Jersey | |
| Michael Schwarz, MDFACC | |
| Bloomfield, New Jersey, United States, 07003 | |
| Respiratory Health & Critical Care Associates | |
| Hawthorne, New Jersey, United States, 07506 | |
| Pulmonary Hypertension & Lung Transplant Program Newark Beth Israel Medical Center | |
| Newark, New Jersey, United States, 07112 | |
| United States, New York | |
| North Shore - LIJ Health System | |
| New Hyde Park, New York, United States, 11040 | |
| Beth Israel Medical Center | |
| New York, New York, United States, 10003 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| East Carolina University | |
| Greenville, North Carolina, United States, 27834 | |
| Wake Forest University Phyisicans Clinic/Pulmonary | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| The Christ Hospital Heart & Vascular Center | |
| Cincinnati, Ohio, United States, 45219 | |
| University of Cincinnati Pulmonary Critical Care & Sleep Medicine | |
| Cincinnati, Ohio, United States, 45219 | |
| University Hospitals Case Medical Center | |
| Cleveland, Ohio, United States, 44106 | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| Dayton Respiratory Center | |
| Dayton, Ohio, United States, 45215 | |
| University of Toledo Health Sciences Campus | |
| Toledo, Ohio, United States, 43614 | |
| United States, Oregon | |
| Heart Center Cardiology | |
| Bend, Oregon, United States, 97701 | |
| United States, Pennsylvania | |
| Central Bucks Specialists - The Pavilion at Doylestown Hospital | |
| Doylestown, Pennsylvania, United States, 18901 | |
| Institute for Respiratory and Sleep Medicine | |
| Langhorne, Pennsylvania, United States, 19007 | |
| Pulmonary Hypertension Program, Cardiology, Children's Hospial of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Pulmonary Vascular Disease Program, Penn Presbyterian Medical Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Temple University Hospital | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Respiratory Specialists | |
| Wyomissing, Pennsylvania, United States, 19610 | |
| Wellspan Lung, Sleep and Critical Care | |
| York, Pennsylvania, United States, 17402 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, South Dakota | |
| Sioux Falls Cardiovascular PC | |
| Sioux Falls, South Dakota, United States, 57103 | |
| United States, Tennessee | |
| Statcare Pulmonary Consultants | |
| Knoxville, Tennessee, United States, 37919 | |
| United States, Texas | |
| El Paso Respiratory and Sleep Consultants | |
| El Paso, Texas, United States, 79902 | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| UT Health - University of Texas Houston | |
| Houston, Texas, United States, 77030 | |
| Providence Health Center | |
| Waco, Texas, United States, 76712 | |
| United States, Virginia | |
| IHVI, Advanced Lung Disease and Transplant Clinic | |
| Falls Church, Virginia, United States, 22042 | |
| Sentara Medical Group | |
| Norfolk, Virginia, United States, 23507 | |
| United States, Washington | |
| Cardiac Study Center | |
| Puyallup, Washington, United States, 98372 | |
| Puerto Rico | |
| PAH Clinic CPR at Auxilio Mutuo | |
| San Juan, Puerto Rico, 00918 | |
Sponsors and Collaborators
Actelion
Canadian Heart Research Centre
Investigators
| Study Chair: | Vallerie McLaughlin, MD | University of Michigan |
| Responsible Party: | Actelion |
| ClinicalTrials.gov Identifier: | NCT01389206 History of Changes |
| Other Study ID Numbers: |
AC-052-428 |
| First Posted: | July 8, 2011 Key Record Dates |
| Last Update Posted: | March 12, 2018 |
| Last Verified: | March 2018 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
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Hypertension Familial Primary Pulmonary Hypertension Vascular Diseases Cardiovascular Diseases Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Iloprost Tezosentan Bosentan |
Selexipag Macitentan Platelet Aggregation Inhibitors Vasodilator Agents Antihypertensive Agents Endothelin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Endothelin A Receptor Antagonists Endothelin B Receptor Antagonists |