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)
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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 |
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Recruitment Status :
Recruiting
First Posted : March 24, 2021
Last Update Posted : March 27, 2023
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Pulmonary Arterial Hypertension | Drug: Riociguat (Adempas, BAY63-2521) |
| Study Type : | Observational |
| Estimated Enrollment : | 500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| 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 |
| Group/Cohort | Intervention/treatment |
|---|---|
| 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
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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 Criteria:
- Previously treated with and discontinued use of riociguat for any reason prior to study enrollment (discontinuation defined as an interruption of therapy ≥30 days)
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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
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 22937 | clinical-trials-contact@bayer.com |
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| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT04813926 |
| Other Study ID Numbers: |
21427 |
| First Posted: | March 24, 2021 Key Record Dates |
| Last Update Posted: | March 27, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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