This trial is active, not recruiting.

Condition pulmonary arterial hypertension
Sponsor Actelion
Collaborator Canadian Heart Research Centre
Start date June 2011
End date January 2018
Trial size 800 participants
Trial identifier NCT01389206, AC-052-428


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Patients with pulmonary arterial hypertension

Primary Outcomes

Patients achieving guideline-recommended treatment
time frame: 3 years

Secondary Outcomes

Patients achieving optimal functional class
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

Official title Pulmonary Arterial Hypertension (PAH) Quality Enhancement Research Initiative (QuERI) Extension Program
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Actelion.