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

Actelion Pharmaceuticals

Status: Completed

Conditions: Pulmonary Arterial Hypertension

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01389206

AC-052-428

Details and patient eligibility

About

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

Full 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)

Enrollment: 797 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

797 participants in 1 patient group

Standard of care

Description:

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.

Treatment:

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