Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program

Completed

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Drug: observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi

• Registration Number: NCT01389206
• Lead Sponsor: Actelion

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)

Study Timeline

• Study Start: 2011-06-01
• Study First Submitted: 2011-07-06
• Study First Submitted QC: 2011-07-07
• Study First Posted: 2011-07-08
• Primary Completion: 2018-04-10
• Study Completion: 2018-04-10
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-14
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 797

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard of care	observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi	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.

Primary Outcome Measures

Name	Time	Method
Patients achieving guideline-recommended treatment	3 years	Proportion of patients achieving guideline-recommended treatment

Secondary Outcome Measures

Name	Time	Method
Patients achieving optimal functional class	3 years	Proportion of patients achieving optimal functional class using an evidence-based treatment algorithm

Trial Locations

Locations (76)

Cardiovascular Associates, PC; 🇺🇸 Birmingham, Alabama, United States

University of South Alabama Medical Center; 🇺🇸 Mobile, Alabama, United States

Pulmonary Associates; 🇺🇸 Phoenix, Arizona, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Alliance Medical and Research Center; 🇺🇸 Fountain Valley, California, United States

Scripps Clinic, Scripps Green Hospital; 🇺🇸 La Jolla, California, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

Paloma Medical Group; 🇺🇸 San Juan Capistrano, California, United States

Harbor-UCLA Medical Center; 🇺🇸 Torrance, California, United States

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States

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