Status:
COMPLETED
A Study to Learn About How Well Riociguat Works, How Safe it is and How it is Used Under Real World Conditions in Patients in the United States Who Are Receiving Riociguat for High Blood Pressure in the Arteries That Carry Blood From the Heart to the Lungs (Pulmonary Arterial Hypertension, PAH)
Lead Sponsor:
Bayer
Collaborating Sponsors:
Xcenda, LLC
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
Brief Summary
Pulmonary arterial hypertension (PAH) is a type of high blood pressure in the arteries that carry blood from the heart to the lungs. PAH occurs when the openings in the blood vessels of the lungs get ...
Eligibility Criteria
Inclusion
- Patients aged ≥18 years at the time of riociguat treatment initiation
- Diagnosis of PAH per National Institute for Health and Care Excellence (NICE) 2018 classification
- Decision to initiate treatment with riociguat as per investigator's routine treatment practice made prior to enrollment in the study
- Initiation of riociguat, as per the FDA-approved US label:
- At enrollment OR
- ≤90 days prior to enrollment, with a documented titration regimen (defined as all documented dose changes including, but not limited to: starting dose and dates and highest tolerated dose and dates)
- Signed informed consent
Exclusion
- Previously treated with and discontinued use of riociguat for any reason prior to study enrollment (discontinuation defined as an interruption of therapy ≥30 days)
- Participating in any of the following:
- Blinded clinical trial
- Clinical trial involving an unapproved drug
- Investigational program with interventions outside of routine clinical practice
- Life expectancy \<12 months
- Contraindicated to receive riociguat per the FDA approved US label
- Use of nitrates or NO donors in any form
- Use of PDE5 inhibitors
- PH associated with idiopathic interstitial pneumonias
- Unable or unwilling to provide informed consent
Key Trial Info
Start Date :
July 16 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 3 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04813926
Start Date
July 16 2021
End Date
February 3 2025
Last Update
February 10 2025
Active Locations (50)
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1
Banner University Medical Center- Phoenix
Phoenix, Arizona, United States, 85006
2
Honor Health
Phoenix, Arizona, United States, 85020
3
Univ of Arizona College of Medicine, Tucson
Tucson, Arizona, United States, 85719
4
UCSF
Fresno, California, United States, 93710