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

This study is ongoing, but not recruiting participants.
Canadian Heart Research Centre
Information provided by (Responsible Party):
Actelion Identifier:
First received: July 6, 2011
Last updated: April 21, 2017
Last verified: April 2017
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.

Pulmonary Arterial Hypertension

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Actelion:

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

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

Estimated Enrollment: 800
Study Start Date: June 1, 2011
Estimated Study Completion Date: March 1, 2018
Estimated Primary Completion Date: January 1, 2018 (Final data collection date for primary outcome measure)
Standard of care
Patients with pulmonary arterial hypertension


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

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
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Please refer to this study by its identifier: NCT01389206

  Show 76 Study Locations
Sponsors and Collaborators
Canadian Heart Research Centre
Study Chair: Vallerie McLaughlin, MD University of Michigan
  More Information

Responsible Party: Actelion Identifier: NCT01389206     History of Changes
Other Study ID Numbers: AC-052-428
Study First Received: July 6, 2011
Last Updated: April 21, 2017

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases processed this record on September 21, 2017