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

This study is currently recruiting participants.
Verified May 2013 by Actelion
Sponsor:
Collaborator:
Canadian Heart Research Centre
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01389206
First received: July 6, 2011
Last updated: May 16, 2013
Last verified: May 2013
History of Changes
  Purpose

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
Pulmonary Arterial Hypertension

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pulmonary Arterial Hypertension (PAH) Quality Enhancement Research Initiative (QuERI) Extension Program

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Actelion:

Primary Outcome Measures:
  • Patients achieving guideline-recommended treatment [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Proportion of patients achieving guideline-recommended treatment


Secondary Outcome Measures:
  • Patients achieving optimal functional class [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Proportion of patients achieving optimal functional class using an evidence-based treatment algorithm


Estimated Enrollment: 800
Study Start Date: June 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Standard of care
Patients with pulmonary arterial hypertension

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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):

    i. Right Heart Catheterization (RHC) demonstrating mean Pulmonary Arterial Pressure (mPAP) > 25mm Hg and Pulmonary Capillary Wedge Pressure (PCWP) ii. Forced Expiratory Volume in the first second (FEV1) > 50% predicted normal iii. 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; c. Patients with pulmonary hypertension classified as group 2 - 5 Dana Point, 2008 updated clinical classification.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01389206

  Show 73 Study Locations
Sponsors and Collaborators
Actelion
Canadian Heart Research Centre
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01389206     History of Changes
Other Study ID Numbers: AC-052-428
Study First Received: July 6, 2011
Last Updated: May 16, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013