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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Canadian Heart Research Centre
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01389206
First received: July 6, 2011
Last updated: March 1, 2016
Last verified: March 2016

July 6, 2011
March 1, 2016
June 2011
January 2018   (final data collection date for primary outcome measure)
Patients achieving guideline-recommended treatment [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Proportion of patients achieving guideline-recommended treatment
Same as current
Complete list of historical versions of study NCT01389206 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program
Pulmonary Arterial Hypertension (PAH) Quality Enhancement Research Initiative (QuERI) Extension Program
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.
Not Provided
Observational [Patient Registry]
Observational Model: Case-Only
Time Perspective: Prospective
3 Years
Not Provided
Non-Probability Sample
PAH patients and Physician practices
Pulmonary Arterial Hypertension
Not Provided
Standard of care
Patients with pulmonary arterial hypertension
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
800
March 2018
January 2018   (final data collection date for primary outcome measure)

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).
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01389206
AC-052-428
No
Not Provided
Not Provided
Actelion
Actelion
Canadian Heart Research Centre
Study Chair: Vallerie McLaughlin, MD University of Michigan
Actelion
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP