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OpenTrials
Completed

NCT Number: NCT01389206

Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

PAH Clinic CPR at Auxilio Mutuo, San Juan, Puerto Rico

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female adults (≥ 18 years of age)
  • 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

  • Diagnosis of PAH < 3 years
  • Need for PAH specific treatment
  • 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 classified as group 2 - 5 Updated Clinical Classification of Pulmonary Hypertension (5th World Symposium on PH Modified Classification of PH)

Treatment and study plan

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

Drug

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

Primary outcomes

  1. Patients achieving guideline-recommended treatment

    Time frame: 3 years

    Proportion of patients achieving guideline-recommended treatment

Secondary outcomes

  1. Patients achieving optimal functional class

    Time frame: 3 years

    Proportion of patients achieving optimal functional class using an evidence-based treatment algorithm

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Collaborators

  • Canadian Heart Research Centre

Registry information

Acronym: PAH QuERI Ext

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Jul 8, 2011
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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