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CARE PAH (Contemporary Real-World PAH Best Practice)

Title

AN INTERNATIONAL, NON-DRUG INTERVENTIONAL, REAL-WORLD COHORT OF PAH PATIENTS NEWLY INITIATING PAH THERAPY WITH GUIDELINE DIRECTED ASSESSMENTS OF DISEASE SEVERITY
Therapeutic Area Pulmonary Hypertension
Principal Investigator Ioana Preston, MD
Min Age 18 Years
Gender Any
Contact Daniel Strick

dstrick@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04955990

Overview

This is a prospective, non-drug interventional, international, multicenter study to collect real-world data from participants who newly initiate any PAH therapy(ies) in a real-world clinical setting, either as first therapies, as replacement therapies, or as additional therapies. 

Study Details

Inclusion Criteria

  • Diagnosis of PAH by Right Heart Catherization meeting the following criteria: Mean pulmonary artery pressure >20 mmHg AND Pulmonary artery wedge pressure or left ventricular end diastolic pressure ≤15 mmHg AND Pulmonary vascular resistance ≥ 3 Wood Units
  • Newly initiating 1 or more PAH therapy(ies)
  • Ability to follow the protocol including all mandated visits and assessments.

Exclusion Criteria

  • Patients enrolled in any interventional clinical trial

Study Requirements

Mandatory clinic visits at the start of any new PAH medication, 3-6 months after therapy change, every 6 months. Clinic visits will involve 6 Minute Walk Test, World Health Organization Functional Class, blood draws at every visit, and questionnaires about your quality of life. There will also be quartertly telephone calls as part of the study.