Pulmonary Arterial HypertensionPAH QuERI ExtNCT01389206
Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program
An observational study of Pulmonary Arterial Hypertension, run by Actelion at 76 sites in 2 countries.
Trial summary
Knowledge Translation Program for the guidelines and evidence-based management of PAH patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi
- How many people
- 797 participants
- Where
- 76 sitesin 2 countries
- Study dates
- 1 Jun 2011to 10 Apr 2018
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 800 PAH patients from approximately 80 physician practices will be included in the program.
Who may be able to join
- Male and female adults (≥ 18 years of age)
- 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
Who cannot join
- 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)
Trial locations and contacts
76 sites in 2 countries.
76 sites in 2 countries
United States75 sites
University of Michigan Pulmonary Hypertension Program
Ann Arbor, Michigan, 48109
University of Colorado Denver
Aurora, Colorado, 80045
University of Maryland Medical Centre
Baltimore, Maryland, 21201
Johns Hopkins University
Baltimore, Maryland, 21287
Heart Center Cardiology
Bend, Oregon, 97701
Cardiovascular Associates, PC
Birmingham, Alabama, 35216
Michael Schwarz, MDFACC
Bloomfield, New Jersey, 07003
Bay Area Cardiology Research, P.A.
Brandon, Florida, 33511
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Illinois at Chicago
Chicago, Illinois, 60612
The Christ Hospital Heart & Vascular Center
Cincinnati, Ohio, 45219
University of Cincinnati Pulmonary Critical Care & Sleep Medicine
Cincinnati, Ohio, 45219
Bay Area Chest Physicians
Clearwater, Florida, 33756
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
Dayton Respiratory Center
Dayton, Ohio, 45215
Wayne State University, Detroit Medical Center
Detroit, Michigan, 48324
Central Bucks Specialists - The Pavilion at Doylestown Hospital
Doylestown, Pennsylvania, 18901
Duke University Medical Center
Durham, North Carolina, 27710
El Paso Respiratory and Sleep Consultants
El Paso, Texas, 79902
IHVI, Advanced Lung Disease and Transplant Clinic
Falls Church, Virginia, 22042
Broward Pulmonary and Sleep Specialists
Fort Lauderdale, Florida, 33316
Pulmonary Diseases, Internal Medicine, Critical Care Medicine
Fort Lauderdale, Florida, 33334
Alliance Medical and Research Center
Fountain Valley, California, 92866
University of Texas Medical Branch
Galveston, Texas, 77555
Spectrum Health
Grand Rapids, Michigan, 49525
East Carolina University
Greenville, North Carolina, 27834
Respiratory Health & Critical Care Associates
Hawthorne, New Jersey, 07506
Baylor College of Medicine
Houston, Texas, 77030
UT Health - University of Texas Houston
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52301
Statcare Pulmonary Consultants
Knoxville, Tennessee, 37919
Scripps Clinic, Scripps Green Hospital
La Jolla, California, 92037
Institute for Respiratory and Sleep Medicine
Langhorne, Pennsylvania, 19007
The Lung Center of Nevada
Las Vegas, Nevada, 89128
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0001
Nebraska Pulmonary Specialties, LLC
Lincoln, Nebraska, 68506
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
South Denver Cardiology Associates PC
Littleton, Colorado, 80120
University of Southern California
Los Angeles, California, 90033
Kentuckiana Pulmonary Associates
Louisville, Kentucky, 40202
University of Louisville School of Medicine
Louisville, Kentucky, 40202
Mount Sinai Medical Centre - Columbia University - Division of Cardiology
Miami Beach, Florida, 33140
University of South Alabama Medical Center
Mobile, Alabama, 36617
North Shore - LIJ Health System
New Hyde Park, New York, 11040
Ochsner Medical Center
New Orleans, Louisiana, 70121
Beth Israel Medical Center
New York, New York, 10003
Lung Health & Sleep Enhancement Center, LLC
Newark, Delaware, 19713
Pulmonary Hypertension & Lung Transplant Program Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Sentara Medical Group
Norfolk, Virginia, 23507
Creighton University Medical Centre - Pulmonary, Critical Care and Sleep Medicine Division
Omaha, Nebraska, 68131
University of Nebraska Medical Center
Omaha, Nebraska, 68198-5300
Central Florida Pulmonary Group, PA
Orlando, Florida, 32803
Unity Point Health Pulmonary Services
Peoria, Illinois, 61602
Pulmonary Hypertension Program, Cardiology, Children's Hospial of Philadelphia
Philadelphia, Pennsylvania, 19104
Pulmonary Vascular Disease Program, Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Pulmonary Associates
Phoenix, Arizona, 85006
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Maine Medical Center
Portland, Maine, 04102
Rhode Island Hospital
Providence, Rhode Island, 02903
Cardiac Study Center
Puyallup, Washington, 98372
Paloma Medical Group
San Juan Capistrano, California, 92675
Lung Associates of Sarasota
Sarasota, Florida, 34239
Sioux Falls Cardiovascular PC
Sioux Falls, South Dakota, 57103
University of Toledo Health Sciences Campus
Toledo, Ohio, 43614
Harbor-UCLA Medical Center
Torrance, California, 90502
William Beaumont Hospital - Troy
Troy, Michigan, 48085
Providence Health Center
Waco, Texas, 76712
Cleveland Clinic Florida
Weston, Florida, 33331
Robert E. Benkert, M.D.P.C.
Wheat Ridge, Colorado, 80033
Wake Forest University Phyisicans Clinic/Pulmonary
Winston-Salem, North Carolina, 27157
Respiratory Specialists
Wyomissing, Pennsylvania, 19610
Wellspan Lung, Sleep and Critical Care
York, Pennsylvania, 17402
About this study
Knowledge Translation Program for the guidelines and evidence-based management of PAH patients
Read the 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)
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or UptraviDrug
observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients achieving guideline-recommended treatment
Proportion of patients achieving guideline-recommended treatment
Measured: 3 years
Secondary outcomes (1)
Patients achieving optimal functional class
Proportion of patients achieving optimal functional class using an evidence-based treatment algorithm
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study start1 Jun 2011
- Primary completion10 Apr 2018
- Study completion10 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 797 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Canadian Heart Research Centre
- Responsible party
- Sponsor
- Investigators
- Vallerie McLaughlin, MD, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389206
- Sponsor's protocol ID
- AC-052-428
- Acronym
- PAH QuERI Ext
- Status last verified
- Aug 2018
- First submitted
- 6 Jul 2011
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program
- ClinicalTrials.gov ID
- NCT01389206
- Acronym / sponsor ID
- PAH QuERI Ext / AC-052-428
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 797 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Collaborators
- Canadian Heart Research Centre
- Study start
- 1 Jun 2011
- Primary completion
- 10 Apr 2018 (actual)
- Study completion
- 10 Apr 2018 (actual)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of care | – | Drug: observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or UptraviObservational 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 800 PAH patients from approximately 80 physician practices will be included in the program.
Key inclusion criteria (6 listed)
- Male and female adults (≥ 18 years of age)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptraviobservational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi | Drug | Standard of care |
Primary outcome
Patients achieving guideline-recommended treatment
Time frame: 3 years
Proportion of patients achieving guideline-recommended treatment
1 secondary outcome
Patients achieving optimal functional class
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vallerie McLaughlin, MD study chair
University of Michigan
76 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by Actelion at 76 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients achieving guideline-recommended treatment (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.