Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program (PAH QuERI Ext)

August 14, 2018 updated by: Actelion
Knowledge Translation Program for the guidelines and evidence-based management of PAH patients

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
797

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00918
        • PAH Clinic CPR at Auxilio Mutuo
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Cardiovascular Associates, Pc
      • Mobile, Alabama, United States, 36617
        • University of South Alabama Medical Center
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Pulmonary Associates
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Fountain Valley, California, United States, 92866
        • Alliance Medical and Research Center
      • La Jolla, California, United States, 92037
        • Scripps Clinic, Scripps Green Hospital
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • San Juan Capistrano, California, United States, 92675
        • Paloma Medical Group
      • Torrance, California, United States, 90502
        • Harbor-UCLA Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver
      • Littleton, Colorado, United States, 80120
        • South Denver Cardiology Associates PC
      • Wheat Ridge, Colorado, United States, 80033
        • Robert E. Benkert, M.D.P.C.
    • Delaware
      • Newark, Delaware, United States, 19713
        • Lung Health & Sleep Enhancement Center, LLC
    • Florida
      • Brandon, Florida, United States, 33511
        • Bay Area Cardiology Research, P.A.
      • Clearwater, Florida, United States, 33756
        • Bay Area Chest Physicians
      • Fort Lauderdale, Florida, United States, 33316
        • Broward Pulmonary and Sleep Specialists
      • Fort Lauderdale, Florida, United States, 33334
        • Pulmonary Diseases, Internal Medicine, Critical Care Medicine
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Centre - Columbia University - Division of Cardiology
      • Orlando, Florida, United States, 32803
        • Central Florida Pulmonary Group, PA
      • Sarasota, Florida, United States, 34239
        • Lung Associates of Sarasota
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
      • Peoria, Illinois, United States, 61602
        • Unity Point Health Pulmonary Services
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Iowa
      • Iowa City, Iowa, United States, 52301
        • University of Iowa Hospitals & Clinics
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Kentuckiana Pulmonary Associates
      • Louisville, Kentucky, United States, 40202
        • University of Louisville School of Medicine
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Centre
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Pulmonary Hypertension Program
      • Detroit, Michigan, United States, 48324
        • Wayne State University, Detroit Medical Center
      • Grand Rapids, Michigan, United States, 49525
        • Spectrum Health
      • Troy, Michigan, United States, 48085
        • William Beaumont Hospital - Troy
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Nebraska Pulmonary Specialties, LLC
      • Omaha, Nebraska, United States, 68131
        • Creighton University Medical Centre - Pulmonary, Critical Care and Sleep Medicine Division
      • Omaha, Nebraska, United States, 68198-5300
        • University Of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • The Lung Center of Nevada
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-0001
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Michael Schwarz, MDFACC
      • Hawthorne, New Jersey, United States, 07506
        • Respiratory Health & Critical Care Associates
      • Newark, New Jersey, United States, 07112
        • Pulmonary Hypertension & Lung Transplant Program Newark Beth Israel Medical Center
    • New York
      • New Hyde Park, New York, United States, 11040
        • North Shore - LIJ Health System
      • New York, New York, United States, 10003
        • Beth Israel Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Greenville, North Carolina, United States, 27834
        • East Carolina University
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Phyisicans Clinic/Pulmonary
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital Heart & Vascular Center
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Pulmonary Critical Care & Sleep Medicine
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center
      • Dayton, Ohio, United States, 45215
        • Dayton Respiratory Center
      • Toledo, Ohio, United States, 43614
        • University of Toledo Health Sciences Campus
    • Oregon
      • Bend, Oregon, United States, 97701
        • Heart Center Cardiology
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
        • Central Bucks Specialists - The Pavilion at Doylestown Hospital
      • Langhorne, Pennsylvania, United States, 19007
        • Institute for Respiratory and Sleep Medicine
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • Pulmonary Hypertension Program, Cardiology, Children's Hospial of Philadelphia
      • Philadelphia, Pennsylvania, United States, 19104
        • Pulmonary Vascular Disease Program, Penn Presbyterian Medical Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
      • Wyomissing, Pennsylvania, United States, 19610
        • Respiratory Specialists
      • York, Pennsylvania, United States, 17402
        • Wellspan Lung, Sleep and Critical Care
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57103
        • Sioux Falls Cardiovascular PC
    • Tennessee
      • Knoxville, Tennessee, United States, 37919
        • Statcare Pulmonary Consultants
    • Texas
      • El Paso, Texas, United States, 79902
        • El Paso Respiratory and Sleep Consultants
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • UT Health - University of Texas Houston
      • Waco, Texas, United States, 76712
        • Providence Health Center
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • IHVI, Advanced Lung Disease and Transplant Clinic
      • Norfolk, Virginia, United States, 23507
        • Sentara Medical Group
    • Washington
      • Puyallup, Washington, United States, 98372
        • Cardiac Study Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Approximately 800 PAH patients from approximately 80 physician practices will be included in the program.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patients achieving guideline-recommended treatment
Time Frame: 3 years
Proportion of patients achieving guideline-recommended treatment
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patients achieving optimal functional class
Time Frame: 3 years
Proportion of patients achieving optimal functional class using an evidence-based treatment algorithm
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Actelion

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Heart Research Centre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Vallerie McLaughlin, MD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 10, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AC-052-428

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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