check_circleStudy Completed
Pulmonary Arterial Hypertension
Bayer Identifier:
21427
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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)
Trial purpose
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.
- 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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
500Trial Dates
July 2021 - February 2025Phase
Phase 4Could I Receive a placebo
NoProducts
Adempas (Riociguat, BAY63-2521)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Not yet recruiting | Beaumont Hospital | Troy, 48085, United States |
Recruiting | Baylor Scott and White | Plano, 75093, United States |
Not yet recruiting | UCSF | Fresno, 93710, United States |
Not yet recruiting | Columbia | New York, 10032, United States |
Not yet recruiting | St Francis Medical Ctr | Columbus, 31904, United States |
Not yet recruiting | Winthrop | Mineola, 11501, United States |
Recruiting | Advocate Christ | Oak Lawn, 60453, United States |
Recruiting | University of Cincinnati | Cincinnati, 45220, United States |
Not yet recruiting | USC | Los Angeles, 90089, United States |
Not yet recruiting | Banner University Medical Center- Phoenix | Phoenix, 85006, United States |
Recruiting | VCU/MCV | Richmond, 23219, United States |
Not yet recruiting | Froedtert/Medical College of Wisconsin | Milwaukee, 53226, United States |
Not yet recruiting | Richmond Pulmonary Associates | Richmond, 23219, United States |
Not yet recruiting | Integris | Oklahoma City, 73112, United States |
Recruiting | Boston University | Boston, 02215, United States |
Not yet recruiting | University of Rochester | Rochester, 14642, United States |
Recruiting | Advent Health | Orlando, 32808, United States |
Not yet recruiting | UNMH | Albuquerque, 87114, United States |
Recruiting | University of Missouri | Columbia, 30309, United States |
Not yet recruiting | St. Louis University | St. Louis, 63103, United States |
Recruiting | Providence | Spokane, 99208, United States |
Recruiting | Loyola | Maywood, 60153, United States |
Not yet recruiting | CCF (Cleveland Clinic Florida) | Weston, 33331, United States |
Recruiting | Allegheny General Hospital | Pittsburgh, 15212, United States |
Recruiting | Tampa General Hospital USF | Tampa, 33606, United States |
Recruiting | Univ of Arizona College of Medicine, Tucson | Tucson, 85719, United States |
Recruiting | Advocate Aurora | Milwaukee, 53215, United States |
Not yet recruiting | Mass General | Boston, 02210, United States |
Recruiting | Santa Barbara Cottage Hospital | Santa Barbara, 93105, United States |
Recruiting | Houston Methodist | Houston, 77030, United States |
Not yet recruiting | Honor Health | Phoenix, 85020, United States |
Recruiting | Legacy Health | Portland, 97232, United States |
Not yet recruiting | UT Southwestern | Dallas, 75390, United States |
Not yet recruiting | UC Davis | Sacramento, 95817, United States |
Not yet recruiting | NYU Langone | New York, 10016, United States |
Recruiting | Northwell Health | New Hyde Park, 11042, United States |
Not yet recruiting | Mount Sinai | New York, 10003, United States |
Not yet recruiting | Temple University | Philadelphia, 19140, United States |
Recruiting | UC Irvine | Irvine, 92697, United States |
Recruiting | Alliance Pulmonary | Guaynabo, 00968, United States |
Not yet recruiting | Barnes / Wash U | St. Louis, 63108, United States |
Recruiting | Northwestern | Chicago, 60611, United States |
Recruiting | Seton Heart | Austin, 78759, United States |
Recruiting | Cedar Sinai | Los Angeles, 90048, United States |
Recruiting | Premier Pulmonary | Denison, 75020, United States |
Recruiting | Norton Pulmonary Specialists | Louisville, 40202, United States |
Recruiting | UCSD | San Diego, 92103, United States |
Recruiting | AnMed Health Medical Center | Anderson, 29621, United States |
Recruiting | KUMC | Kansas City, 66160, United States |
Recruiting | UNMC | Omaha, 68198, United States |
Primary Outcome
- Incidence of adverse events (AEs) and serious adverse events (SAEs)date_rangeTime Frame:Up to 24 months
- Change of 6-minute walk distance (6MWD) from baseline to Months 6, 12, and 24date_rangeTime Frame:At baseline, Month 6, 12, and 24
- Change of NT-proBNP from baseline to Months 6, 12, and 24NT-proBNP: N-terminal pro-hormone B-type natriuretic peptidedate_rangeTime Frame:At baseline, Month 6, 12, and 24
- Change of BNP from baseline to Months 6, 12, and 24BNP: B-type natriuretic peptidedate_rangeTime Frame:At baseline, Month 6, 12, and 24
- Change of clinical PAH scores from baseline to Months 6, 12, and 24date_rangeTime Frame:At baseline, Month 6, 12, and 24
- Change of hemodynamic measurements from RHC from baseline to Months 6, 12, and 24RHC: Right-heart catheterizationdate_rangeTime Frame:At baseline, Month 6, 12, and 24
- Change of ECHO measurements from baseline to Months 6, 12, and 24ECHO: Echocardiogramdate_rangeTime Frame:At baseline, Month 6, 12, and 24
- Change of laboratory tests from baseline to Months 6, 12, and 24date_rangeTime Frame:At baseline, Month 6, 12, and 24
- Change of NYHA/WHO PH functional class from baseline to Months 6, 12, and 24NYHA: New York Heart Association WHO: World Health Organizationdate_rangeTime Frame:At baseline, Month 6, 12, and 24
Secondary Outcome
- Change from baseline to Month 6 and change from baseline to Month 12 in Borg Dysponea Indexdate_rangeTime Frame:At baseline, Month 6 and Month 12
- Change from baseline to Month 6 and change from baseline to Month 12 in emPHasis-10date_rangeTime Frame:At baseline, Month 6 and Month 12
- Persistence/discontinuation rates for riociguatdate_rangeTime Frame:Up to 24 months
- Reasons for discontinuation of riociguatdate_rangeTime Frame:At Month 6, 12, and 24 post-baseline
- Real-world treatment patterns for riociguat for PAHdate_rangeTime Frame:Up to 24 months
- Demographic of patients treated with riociguatdate_rangeTime Frame:Up to 24 months
- Clinical characteristics of patients treated with riociguatdate_rangeTime Frame:Up to 24 months
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A