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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01389206
Recruitment Status : Active, not recruiting
First Posted : July 8, 2011
Last Update Posted : March 12, 2018
Sponsor:
Collaborator:
Canadian Heart Research Centre
Information provided by (Responsible Party):
Actelion

July 6, 2011
July 8, 2011
March 12, 2018
June 1, 2011
June 30, 2018   (Final data collection date for primary outcome measure)
Patients achieving guideline-recommended treatment [ Time Frame: 3 years ]
Proportion of patients achieving guideline-recommended treatment
Same as current
Complete list of historical versions of study NCT01389206 on ClinicalTrials.gov Archive Site
Patients achieving optimal functional class [ Time Frame: 3 years ]
Proportion of patients achieving optimal functional class using an evidence-based treatment algorithm
Same as current
Not Provided
Not Provided
 
Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program
Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program
Knowledge Translation Program for the guidelines and evidence-based management of PAH patients
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)
Observational [Patient Registry]
Observational Model: Case-Only
Time Perspective: Prospective
3 Years
Not Provided
Non-Probability Sample
Approximately 800 PAH patients from approximately 80 physician practices will be included in the program.
Pulmonary Arterial Hypertension
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
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.
Intervention: Drug: observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
797
800
June 30, 2018
June 30, 2018   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT01389206
AC-052-428
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Actelion
Actelion
Canadian Heart Research Centre
Study Chair: Vallerie McLaughlin, MD University of Michigan
Actelion
March 2018