Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program

Overview

Knowledge Translation Program for the guidelines and evidence-based management of PAH patients

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 10, 2018

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)

Interventions

  • Drug: observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi
    • observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Patients achieving guideline-recommended treatment
    • Time Frame: 3 years
    • Proportion of patients achieving guideline-recommended treatment

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

1. Male and female adults (≥ 18 years of age) 2. 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 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: 1. 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 2. Prior participation in this program 3. Patients with pulmonary hypertension classified as group 2 – 5 Updated Clinical Classification of Pulmonary Hypertension (5th World Symposium on PH Modified Classification of PH)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Actelion
  • Collaborator
    • Canadian Heart Research Centre
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Vallerie McLaughlin, MD, Study Chair, University of Michigan

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