Clinical trial NCT01389206: Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program
Official title: Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Actelion
Sponsor class: INDUSTRY
Collaborators: name: Canadian Heart Research Centre
First posted: 2011-07-08
Enrollment: 797
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 800 PAH patients from approximately 80 physician practices will be included in the program.

Brief summary: Knowledge Translation Program for the guidelines and evidence-based management of PAH patients

Detailed description: 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)

Eligibility criteria: Inclusion Criteria:

1. Male and female adults (≥ 18 years of age)
2. 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
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:

1. 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
2. Prior participation in this program
3. Patients with pulmonary hypertension classified as group 2 - 5 Updated Clinical Classification of Pulmonary Hypertension (5th World Symposium on PH Modified Classification of PH)

Primary outcomes:
measure: Patients achieving guideline-recommended treatment
timeFrame: 3 years
Secondary outcomes:
measure: Patients achieving optimal functional class
timeFrame: 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiovascular Associates, PC
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama Medical Center
state: Alabama
city: Phoenix
country: United States
facility: Pulmonary Associates
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Fountain Valley
country: United States
facility: Alliance Medical and Research Center
state: California
city: La Jolla
country: United States
facility: Scripps Clinic, Scripps Green Hospital
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: San Juan Capistrano
country: United States
facility: Paloma Medical Group
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Littleton
country: United States
facility: South Denver Cardiology Associates PC
state: Colorado
city: Wheat Ridge
country: United States
facility: Robert E. Benkert, M.D.P.C.
state: Colorado
city: Newark
country: United States
facility: Lung Health & Sleep Enhancement Center, LLC
state: Delaware
city: Brandon
country: United States
facility: Bay Area Cardiology Research, P.A.
state: Florida
city: Clearwater
country: United States
facility: Bay Area Chest Physicians
state: Florida
city: Fort Lauderdale
country: United States
facility: Broward Pulmonary and Sleep Specialists
state: Florida
city: Fort Lauderdale
country: United States
facility: Pulmonary Diseases, Internal Medicine, Critical Care Medicine
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Centre - Columbia University - Division of Cardiology
state: Florida
city: Orlando
country: United States
facility: Central Florida Pulmonary Group, PA
state: Florida
city: Sarasota
country: United States
facility: Lung Associates of Sarasota
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Peoria
country: United States
facility: Unity Point Health Pulmonary Services
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Louisville
country: United States
facility: Kentuckiana Pulmonary Associates
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville School of Medicine
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: University of Maryland Medical Centre
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Pulmonary Hypertension Program
state: Michigan
city: Detroit
country: United States
facility: Wayne State University, Detroit Medical Center
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital - Troy
state: Michigan
city: Lincoln
country: United States
facility: Nebraska Pulmonary Specialties, LLC
state: Nebraska
city: Omaha
country: United States
facility: Creighton University Medical Centre - Pulmonary, Critical Care and Sleep Medicine Division
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: The Lung Center of Nevada
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Bloomfield
country: United States
facility: Michael Schwarz, MDFACC
state: New Jersey
city: Hawthorne
country: United States
facility: Respiratory Health & Critical Care Associates
state: New Jersey
city: Newark
country: United States
facility: Pulmonary Hypertension & Lung Transplant Program Newark Beth Israel Medical Center
state: New Jersey
city: New Hyde Park
country: United States
facility: North Shore - LIJ Health System
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Phyisicans Clinic/Pulmonary
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital Heart & Vascular Center
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Pulmonary Critical Care & Sleep Medicine
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Dayton
country: United States
facility: Dayton Respiratory Center
state: Ohio
city: Toledo
country: United States
facility: University of Toledo Health Sciences Campus
state: Ohio
city: Bend
country: United States
facility: Heart Center Cardiology
state: Oregon
city: Doylestown
country: United States
facility: Central Bucks Specialists - The Pavilion at Doylestown Hospital
state: Pennsylvania
city: Langhorne
country: United States
facility: Institute for Respiratory and Sleep Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pulmonary Hypertension Program, Cardiology, Children's Hospial of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pulmonary Vascular Disease Program, Penn Presbyterian Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Wyomissing
country: United States
facility: Respiratory Specialists
state: Pennsylvania
city: York
country: United States
facility: Wellspan Lung, Sleep and Critical Care
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Sioux Falls
country: United States
facility: Sioux Falls Cardiovascular PC
state: South Dakota
city: Knoxville
country: United States
facility: Statcare Pulmonary Consultants
state: Tennessee
city: El Paso
country: United States
facility: El Paso Respiratory and Sleep Consultants
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: UT Health - University of Texas Houston
state: Texas
city: Waco
country: United States
facility: Providence Health Center
state: Texas
city: Falls Church
country: United States
facility: IHVI, Advanced Lung Disease and Transplant Clinic
state: Virginia
city: Norfolk
country: United States
facility: Sentara Medical Group
state: Virginia
city: Puyallup
country: United States
facility: Cardiac Study Center
state: Washington
city: San Juan
country: Puerto Rico
facility: PAH Clinic CPR at Auxilio Mutuo
Study officials:
affiliation: University of Michigan
name: Vallerie McLaughlin, MD
role: STUDY_CHAIR
References: