Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program

NCT ID: NCT01389206

Last Updated: 2018-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

797 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-01

Study Completion Date

2018-04-10

Brief Summary

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

Detailed Description

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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)

Conditions

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Pulmonary Arterial Hypertension

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi

Intervention Type DRUG

observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Heart Research Centre

OTHER

Sponsor Role collaborator

Actelion

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vallerie McLaughlin, MD

Role: STUDY_CHAIR

University of Michigan

Locations

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Cardiovascular Associates, PC

Birmingham, Alabama, United States

Site Status

University of South Alabama Medical Center

Mobile, Alabama, United States

Site Status

Pulmonary Associates

Phoenix, Arizona, United States

Site Status

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Alliance Medical and Research Center

Fountain Valley, California, United States

Site Status

Scripps Clinic, Scripps Green Hospital

La Jolla, California, United States

Site Status

University of Southern California

Los Angeles, California, United States

Site Status

Paloma Medical Group

San Juan Capistrano, California, United States

Site Status

Harbor-UCLA Medical Center

Torrance, California, United States

Site Status

University of Colorado Denver

Aurora, Colorado, United States

Site Status

South Denver Cardiology Associates PC

Littleton, Colorado, United States

Site Status

Robert E. Benkert, M.D.P.C.

Wheat Ridge, Colorado, United States

Site Status

Lung Health & Sleep Enhancement Center, LLC

Newark, Delaware, United States

Site Status

Bay Area Cardiology Research, P.A.

Brandon, Florida, United States

Site Status

Bay Area Chest Physicians

Clearwater, Florida, United States

Site Status

Broward Pulmonary and Sleep Specialists

Fort Lauderdale, Florida, United States

Site Status

Pulmonary Diseases, Internal Medicine, Critical Care Medicine

Fort Lauderdale, Florida, United States

Site Status

Mount Sinai Medical Centre - Columbia University - Division of Cardiology

Miami Beach, Florida, United States

Site Status

Central Florida Pulmonary Group, PA

Orlando, Florida, United States

Site Status

Lung Associates of Sarasota

Sarasota, Florida, United States

Site Status

Cleveland Clinic Florida

Weston, Florida, United States

Site Status

University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

Unity Point Health Pulmonary Services

Peoria, Illinois, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

Site Status

Kentuckiana Pulmonary Associates

Louisville, Kentucky, United States

Site Status

University of Louisville School of Medicine

Louisville, Kentucky, United States

Site Status

Ochsner Medical Center

New Orleans, Louisiana, United States

Site Status

Maine Medical Center

Portland, Maine, United States

Site Status

University of Maryland Medical Centre

Baltimore, Maryland, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

University of Michigan Pulmonary Hypertension Program

Ann Arbor, Michigan, United States

Site Status

Wayne State University, Detroit Medical Center

Detroit, Michigan, United States

Site Status

Spectrum Health

Grand Rapids, Michigan, United States

Site Status

William Beaumont Hospital - Troy

Troy, Michigan, United States

Site Status

Nebraska Pulmonary Specialties, LLC

Lincoln, Nebraska, United States

Site Status

Creighton University Medical Centre - Pulmonary, Critical Care and Sleep Medicine Division

Omaha, Nebraska, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

The Lung Center of Nevada

Las Vegas, Nevada, United States

Site Status

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Michael Schwarz, MDFACC

Bloomfield, New Jersey, United States

Site Status

Respiratory Health & Critical Care Associates

Hawthorne, New Jersey, United States

Site Status

Pulmonary Hypertension & Lung Transplant Program Newark Beth Israel Medical Center

Newark, New Jersey, United States

Site Status

North Shore - LIJ Health System

New Hyde Park, New York, United States

Site Status

Beth Israel Medical Center

New York, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

East Carolina University

Greenville, North Carolina, United States

Site Status

Wake Forest University Phyisicans Clinic/Pulmonary

Winston-Salem, North Carolina, United States

Site Status

The Christ Hospital Heart & Vascular Center

Cincinnati, Ohio, United States

Site Status

University of Cincinnati Pulmonary Critical Care & Sleep Medicine

Cincinnati, Ohio, United States

Site Status

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Dayton Respiratory Center

Dayton, Ohio, United States

Site Status

University of Toledo Health Sciences Campus

Toledo, Ohio, United States

Site Status

Heart Center Cardiology

Bend, Oregon, United States

Site Status

Central Bucks Specialists - The Pavilion at Doylestown Hospital

Doylestown, Pennsylvania, United States

Site Status

Institute for Respiratory and Sleep Medicine

Langhorne, Pennsylvania, United States

Site Status

Pulmonary Hypertension Program, Cardiology, Children's Hospial of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Pulmonary Vascular Disease Program, Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Site Status

Temple University Hospital

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Respiratory Specialists

Wyomissing, Pennsylvania, United States

Site Status

Wellspan Lung, Sleep and Critical Care

York, Pennsylvania, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Sioux Falls Cardiovascular PC

Sioux Falls, South Dakota, United States

Site Status

Statcare Pulmonary Consultants

Knoxville, Tennessee, United States

Site Status

El Paso Respiratory and Sleep Consultants

El Paso, Texas, United States

Site Status

University of Texas Medical Branch

Galveston, Texas, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

UT Health - University of Texas Houston

Houston, Texas, United States

Site Status

Providence Health Center

Waco, Texas, United States

Site Status

IHVI, Advanced Lung Disease and Transplant Clinic

Falls Church, Virginia, United States

Site Status

Sentara Medical Group

Norfolk, Virginia, United States

Site Status

Cardiac Study Center

Puyallup, Washington, United States

Site Status

PAH Clinic CPR at Auxilio Mutuo

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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AC-052-428

Identifier Type: -

Identifier Source: org_study_id

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