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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01389206
Recruitment Status : Active, not recruiting
First Posted : July 8, 2011
Last Update Posted : April 25, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Pulmonary Arterial Hypertension

Study Design

Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
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
Study Start Date : June 1, 2011
Estimated Primary Completion Date : January 1, 2018
Estimated Study Completion Date : March 1, 2018


Groups and Cohorts

Group/Cohort
Standard of care
Patients with pulmonary arterial hypertension


Outcome Measures

Primary Outcome Measures :
  1. Patients achieving guideline-recommended treatment [ Time Frame: 3 years ]
    Proportion of patients achieving guideline-recommended treatment


Secondary Outcome Measures :
  1. Patients achieving optimal functional class [ Time Frame: 3 years ]
    Proportion of patients achieving optimal functional class using an evidence-based treatment algorithm


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
PAH patients and Physician practices
Criteria

Inclusion Criteria:

  1. Male and female adults (>/= 18 years of age)
  2. 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
  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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01389206


  Show 76 Study Locations
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
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases