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)
ROAR
RiOciguAt UseRs Registry
1 other identifier
observational
500
2 countries
50
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 smaller and smaller. These smaller openings can be caused by the following:
- The walls of the arteries tightening
- The walls of the arteries becoming stiff and narrow from an overgrowth of cells The increased pressure in the pulmonary arteries strains the right side of the heart and it begins to fail, causing difficulty breathing and other symptoms. As PAH progresses, symptoms get worse. There is no cure for PAH, but several medications like endothelin receptor antagonists (ERAs), prostacyclin analogues (PCAs) and riociguat, a soluable guanylate cyclase stimulator, are available to help slow the progression of changes in the pulmonary arteries and help reduce symptoms. Riociguat can be taken together with ERAs and PCAs. In this study, the researchers want to learn about how well riociguat works, how safe it is when patients take it in 1 of these ways:
- alone
- with ERA
- with PCA
- with ERA and PCA The dosage for each patient will be decided by their doctor. The researchers will review information collected from the patients who have decided with their doctor to start riociguat treatment for their PAH. The study will include about 500 patients in the United States who are at least 18 years old. All of the patients will have either just started taking riociguat or will have been taking it for less than 3 months No investigational products will be administered in this study. Patients will be treated with the Standard of Care (SOC) for PAH. The SOC is the currently appropriate treatment in accordance with scientific evidence and agreed upon in collaboration between medical experts for PAH. There will be no study-mandated visits or treatments. The patients will be in the study for up to 2 years. During this time, they will visit their doctor every 3 to 6 months as part of the Standard of Care. At these visits, the patients will answer questions about their PAH symptoms and whether they have any medical problems. They will also do exercise tests to see how well they are able to breathe and how tired they get while exercising. The doctors will perform other usual examinations which are part of the Standard of Care such as echocardiograms (images of the heart to show how the heart is working) and a right heart catheters (to measure the pressures in the heart) and will take the usual blood and urine samples.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
Typical duration for all trials
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2021
CompletedFirst Posted
Study publicly available on registry
March 24, 2021
CompletedStudy Start
First participant enrolled
July 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 19, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 3, 2025
CompletedFebruary 10, 2025
February 1, 2025
3.3 years
March 22, 2021
February 7, 2025
Conditions
Outcome Measures
Primary Outcomes (9)
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Up to 24 months
Change of 6-minute walk distance (6MWD) from baseline to Months 6, 12, and 24
At baseline, Month 6, 12, and 24
Change of NT-proBNP from baseline to Months 6, 12, and 24
NT-proBNP: N-terminal pro-hormone B-type natriuretic peptide
At baseline, Month 6, 12, and 24
Change of BNP from baseline to Months 6, 12, and 24
BNP: B-type natriuretic peptide
At baseline, Month 6, 12, and 24
Change of clinical PAH scores from baseline to Months 6, 12, and 24
At baseline, Month 6, 12, and 24
Change of hemodynamic measurements from RHC from baseline to Months 6, 12, and 24
RHC: Right-heart catheterization
At baseline, Month 6, 12, and 24
Change of ECHO measurements from baseline to Months 6, 12, and 24
ECHO: Echocardiogram
At baseline, Month 6, 12, and 24
Change of laboratory tests from baseline to Months 6, 12, and 24
At baseline, Month 6, 12, and 24
Change of NYHA/WHO PH functional class from baseline to Months 6, 12, and 24
NYHA: New York Heart Association WHO: World Health Organization
At baseline, Month 6, 12, and 24
Secondary Outcomes (7)
Change from baseline to Month 6 and change from baseline to Month 12 in Borg Dysponea Index
At baseline, Month 6 and Month 12
Change from baseline to Month 6 and change from baseline to Month 12 in emPHasis-10
At baseline, Month 6 and Month 12
Persistence/discontinuation rates for riociguat
Up to 24 months
Reasons for discontinuation of riociguat
At Month 6, 12, and 24 post-baseline
Real-world treatment patterns for riociguat for PAH
Up to 24 months
- +2 more secondary outcomes
Study Arms (1)
Patients diagnosed with PAH
Interventions
Eligibility Criteria
US patients aged ≥18 years, diagnosed with PAH, who are naĂ¯ve to and initiating treatment with riociguat as per the FDA approved US label for PAH - either at study enrollment or have initiated riociguat within 90 days prior to study enrollment.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Xcenda, LLCcollaborator
Study Sites (50)
Banner University Medical Center- Phoenix
Phoenix, Arizona, 85006, United States
Honor Health
Phoenix, Arizona, 85020, United States
Univ of Arizona College of Medicine, Tucson
Tucson, Arizona, 85719, United States
UCSF
Fresno, California, 93710, United States
UC Irvine
Irvine, California, 92697, United States
Cedar Sinai
Los Angeles, California, 90048, United States
USC
Los Angeles, California, 90089, United States
UC Davis
Sacramento, California, 95817, United States
UCSD
San Diego, California, 92103, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105, United States
Advent Health
Orlando, Florida, 32808, United States
Tampa General Hospital USF
Tampa, Florida, 33606, United States
CCF (Cleveland Clinic Florida)
Weston, Florida, 33331, United States
St Francis Medical Ctr
Columbus, Georgia, 31904, United States
Northwestern
Chicago, Illinois, 60611, United States
Loyola
Maywood, Illinois, 60153, United States
Advocate Christ
Oak Lawn, Illinois, 60453, United States
KUMC
Kansas City, Kansas, 66160, United States
Norton Pulmonary Specialists
Louisville, Kentucky, 40202, United States
Mass General
Boston, Massachusetts, 02210, United States
Boston University
Boston, Massachusetts, 02215, United States
Beaumont Hospital
Troy, Michigan, 48085, United States
University of Missouri
Columbia, Missouri, 30309, United States
St. Louis University
St Louis, Missouri, 63103, United States
Barnes / Wash U
St Louis, Missouri, 63108, United States
UNMC
Omaha, Nebraska, 68198, United States
UNMH
Albuquerque, New Mexico, 87114, United States
Winthrop
Mineola, New York, 11501, United States
Northwell Health
New Hyde Park, New York, 11042, United States
Mount Sinai
New York, New York, 10003, United States
NYU Langone
New York, New York, 10016, United States
Columbia
New York, New York, 10032, United States
University of Rochester
Rochester, New York, 14642, United States
University of Cincinnati
Cincinnati, Ohio, 45220, United States
Integris
Oklahoma City, Oklahoma, 73112, United States
Legacy Health
Portland, Oregon, 97232, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
AnMed Health Medical Center
Anderson, South Carolina, 29621, United States
Seton Heart
Austin, Texas, 78759, United States
UT Southwestern
Dallas, Texas, 75390, United States
Premier Pulmonary
Denison, Texas, 75020, United States
Houston Methodist
Houston, Texas, 77030, United States
Baylor Scott and White
Plano, Texas, 75093, United States
Richmond Pulmonary Associates
Richmond, Virginia, 23219, United States
VCU/MCV
Richmond, Virginia, 23219, United States
Providence
Spokane, Washington, 99208, United States
Advocate Aurora
Milwaukee, Wisconsin, 53215, United States
Froedtert/Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Alliance Pulmonary
Guaynabo, 00968, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2021
First Posted
March 24, 2021
Study Start
July 16, 2021
Primary Completion
October 19, 2024
Study Completion
February 3, 2025
Last Updated
February 10, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.