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Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program

Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01389206
Acronym
PAH QuERI Ext
Enrollment
797
Registered
2011-07-08
Start date
2011-06-01
Completion date
2018-04-10
Last updated
2018-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension

Brief summary

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

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

DRUGobservational 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

Sponsors

Canadian Heart Research Centre
CollaboratorOTHER
Actelion
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Patients achieving guideline-recommended treatment3 yearsProportion of patients achieving guideline-recommended treatment

Secondary

MeasureTime frameDescription
Patients achieving optimal functional class3 yearsProportion of patients achieving optimal functional class using an evidence-based treatment algorithm

Countries

Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026