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

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ClinicalTrials.gov Identifier: NCT01389206
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : August 15, 2018
Sponsor:
Collaborator:
Canadian Heart Research Centre
Information provided by (Responsible Party):
Actelion

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

Condition or disease Intervention/treatment
Pulmonary Arterial Hypertension Drug: observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi

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)

Study Type : Observational [Patient Registry]
Actual Enrollment : 797 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program
Study Start Date : June 1, 2011
Actual Primary Completion Date : April 10, 2018
Actual Study Completion Date : April 10, 2018


Group/Cohort Intervention/treatment
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.
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




Primary Outcome Measures :
  1. Patients achieving guideline-recommended treatment [ Time Frame: 3 years ]
    Proportion of patients achieving guideline-recommended treatment


Secondary Outcome Measures :
  1. Patients achieving optimal functional class [ Time Frame: 3 years ]
    Proportion of patients achieving optimal functional class using an evidence-based treatment algorithm



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Approximately 800 PAH patients from approximately 80 physician practices will be included in the program.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01389206


  Show 76 Study Locations
Sponsors and Collaborators
Actelion
Canadian Heart Research Centre
Investigators
Study Chair: Vallerie McLaughlin, MD University of Michigan

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01389206     History of Changes
Other Study ID Numbers: AC-052-428
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Iloprost
Tezosentan
Bosentan
Selexipag
Macitentan
Platelet Aggregation Inhibitors
Vasodilator Agents
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Endothelin A Receptor Antagonists
Endothelin B Receptor Antagonists