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)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04813926|
Recruitment Status : Recruiting
First Posted : March 24, 2021
Last Update Posted : January 23, 2023
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:
- 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.
|Condition or disease||Intervention/treatment|
|Pulmonary Arterial Hypertension||Drug: Riociguat (Adempas, BAY63-2521)|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||RiOciguAt UseRs Registry|
|Actual Study Start Date :||July 16, 2021|
|Estimated Primary Completion Date :||July 11, 2025|
|Estimated Study Completion Date :||July 11, 2025|
|Patients diagnosed with PAH||
Drug: Riociguat (Adempas, BAY63-2521)
Follow clinical practice.
- Incidence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to 24 months ]
- Change of 6-minute walk distance (6MWD) from baseline to Months 6, 12, and 24 [ Time Frame: At baseline, Month 6, 12, and 24 ]
- Change of NT-proBNP from baseline to Months 6, 12, and 24 [ Time Frame: At baseline, Month 6, 12, and 24 ]NT-proBNP: N-terminal pro-hormone B-type natriuretic peptide
- Change of BNP from baseline to Months 6, 12, and 24 [ Time Frame: At baseline, Month 6, 12, and 24 ]BNP: B-type natriuretic peptide
- Change of clinical PAH scores from baseline to Months 6, 12, and 24 [ Time Frame: At baseline, Month 6, 12, and 24 ]
- Change of hemodynamic measurements from RHC from baseline to Months 6, 12, and 24 [ Time Frame: At baseline, Month 6, 12, and 24 ]RHC: Right-heart catheterization
- Change of ECHO measurements from baseline to Months 6, 12, and 24 [ Time Frame: At baseline, Month 6, 12, and 24 ]ECHO: Echocardiogram
- Change of laboratory tests from baseline to Months 6, 12, and 24 [ Time Frame: At baseline, Month 6, 12, and 24 ]
- Change of NYHA/WHO PH functional class from baseline to Months 6, 12, and 24 [ Time Frame: At baseline, Month 6, 12, and 24 ]NYHA: New York Heart Association WHO: World Health Organization
- Change from baseline to Month 6 and change from baseline to Month 12 in Borg Dysponea Index [ Time Frame: At baseline, Month 6 and Month 12 ]
- Change from baseline to Month 6 and change from baseline to Month 12 in emPHasis-10 [ Time Frame: At baseline, Month 6 and Month 12 ]
- Persistence/discontinuation rates for riociguat [ Time Frame: Up to 24 months ]
- Reasons for discontinuation of riociguat [ Time Frame: At Month 6, 12, and 24 post-baseline ]
- Real-world treatment patterns for riociguat for PAH [ Time Frame: Up to 24 months ]
- Demographic of patients treated with riociguat [ Time Frame: Up to 24 months ]
- Clinical characteristics of patients treated with riociguat [ Time Frame: Up to 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04813926
|Contact: Bayer Clinical Trials Contact||(+)1-888-84 firstname.lastname@example.org|