Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program (PAH QuERI Ext)
This study is ongoing, but not recruiting participants.
Sponsor:
Actelion
Collaborator:
Canadian Heart Research Centre
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01389206
First received: July 6, 2011
Last updated: March 1, 2016
Last verified: March 2016
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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 [Patient Registry] |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Target Follow-Up Duration: | 3 Years |
| 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 2018 |
| Estimated Primary Completion Date: | January 2018 (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 (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
PAH patients and Physician practices
Criteria
Inclusion Criteria:
- Male and female adults (>/= 18 years of age)
-
Documented diagnosis of pulmonary arterial hypertension (PAH) (all of the following):
- Right Heart Catheterization (RHC) demonstrating mean Pulmonary Arterial Pressure (mPAP) > 25mm Hg and Pulmonary Capillary Wedge Pressure (PCWP) <= 15 and PVR > 3
- Forced Expiratory Volume in the first second (FEV1) > 50% predicted normal
- 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
- Patients with Pulmonary Hypertension (PH) classified as group 2 - 5 Updated Clinical Classification of PH (5th World Symposium on PH Modified Classification of PH).
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 | |
| 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. | |
| Wheatridge, 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 | |
| Sious 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 |
More Information
| 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: | March 1, 2016 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Hypertension Familial Primary Pulmonary Hypertension Vascular Diseases Cardiovascular Diseases |
Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on September 30, 2016