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Pulmonary Arterial HypertensionROARNCT04813926

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)

An observational study of Pulmonary Arterial Hypertension, run by Bayer at 50 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
Riociguat (Adempas, BAY63-2521)
How many people
500 participants
Where
50 sitesin 2 countries
Study dates
16 Jul 2021to 3 Feb 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: US patients aged ≥18 years, diagnosed with PAH, who are naïve 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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

50 sites in 2 countries.

50 sites in 2 countries

United States49 sites

  • UNMH

    Albuquerque, New Mexico, 87114

  • AnMed Health Medical Center

    Anderson, South Carolina, 29621

  • Seton Heart

    Austin, Texas, 78759

  • Mass General

    Boston, Massachusetts, 02210

  • Boston University

    Boston, Massachusetts, 02215

  • Northwestern

    Chicago, Illinois, 60611

  • University of Cincinnati

    Cincinnati, Ohio, 45220

  • University of Missouri

    Columbia, Missouri, 30309

  • St Francis Medical Ctr

    Columbus, Georgia, 31904

  • UT Southwestern

    Dallas, Texas, 75390

  • Premier Pulmonary

    Denison, Texas, 75020

  • UCSF

    Fresno, California, 93710

  • Houston Methodist

    Houston, Texas, 77030

  • UC Irvine

    Irvine, California, 92697

  • KUMC

    Kansas City, Kansas, 66160

  • Cedar Sinai

    Los Angeles, California, 90048

  • USC

    Los Angeles, California, 90089

  • Norton Pulmonary Specialists

    Louisville, Kentucky, 40202

  • Loyola

    Maywood, Illinois, 60153

  • Advocate Aurora

    Milwaukee, Wisconsin, 53215

  • Froedtert/Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Winthrop

    Mineola, New York, 11501

  • Northwell Health

    New Hyde Park, New York, 11042

  • Mount Sinai

    New York, New York, 10003

  • NYU Langone

    New York, New York, 10016

  • Columbia

    New York, New York, 10032

  • Advocate Christ

    Oak Lawn, Illinois, 60453

  • Integris

    Oklahoma City, Oklahoma, 73112

  • UNMC

    Omaha, Nebraska, 68198

  • Advent Health

    Orlando, Florida, 32808

  • Temple University

    Philadelphia, Pennsylvania, 19140

  • Banner University Medical Center- Phoenix

    Phoenix, Arizona, 85006

  • Honor Health

    Phoenix, Arizona, 85020

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Baylor Scott and White

    Plano, Texas, 75093

  • Legacy Health

    Portland, Oregon, 97232

  • Richmond Pulmonary Associates

    Richmond, Virginia, 23219

  • VCU/MCV

    Richmond, Virginia, 23219

  • University of Rochester

    Rochester, New York, 14642

  • UC Davis

    Sacramento, California, 95817

  • UCSD

    San Diego, California, 92103

  • Santa Barbara Cottage Hospital

    Santa Barbara, California, 93105

  • Providence

    Spokane, Washington, 99208

  • St. Louis University

    St Louis, Missouri, 63103

  • Barnes / Wash U

    St Louis, Missouri, 63108

  • Tampa General Hospital USF

    Tampa, Florida, 33606

  • Beaumont Hospital

    Troy, Michigan, 48085

  • Univ of Arizona College of Medicine, Tucson

    Tucson, Arizona, 85719

  • CCF (Cleveland Clinic Florida)

    Weston, Florida, 33331

Other trials in United States

Puerto Rico1 site

  • Alliance Pulmonary

    Guaynabo, 00968

Other trials in Puerto Rico

About this study

Official title: RiOciguAt UseRs Registry

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.
Read more

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.

Being tested
Riociguat (Adempas, BAY63-2521)
Medical subject headings
Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Riociguat (Adempas, BAY63-2521)Drug

    Follow clinical practice.

Study groups in NCT04813926
Study groupRoleWhat they receive
Patients diagnosed with PAHNot described
Receives: Drug: Riociguat (Adempas, BAY63-2521)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events (AEs) and serious adverse events (SAEs)

    Measured: Up to 24 months

  2. Change of 6-minute walk distance (6MWD) from baseline to Months 6, 12, and 24

    Measured: At baseline, Month 6, 12, and 24

  3. Change of NT-proBNP from baseline to Months 6, 12, and 24

    NT-proBNP: N-terminal pro-hormone B-type natriuretic peptide

    Measured: At baseline, Month 6, 12, and 24

  4. Change of BNP from baseline to Months 6, 12, and 24

    BNP: B-type natriuretic peptide

    Measured: At baseline, Month 6, 12, and 24

  5. Change of clinical PAH scores from baseline to Months 6, 12, and 24

    Measured: At baseline, Month 6, 12, and 24

  6. Change of hemodynamic measurements from RHC from baseline to Months 6, 12, and 24

    RHC: Right-heart catheterization

    Measured: At baseline, Month 6, 12, and 24

  7. Change of ECHO measurements from baseline to Months 6, 12, and 24

    ECHO: Echocardiogram

    Measured: At baseline, Month 6, 12, and 24

  8. Change of laboratory tests from baseline to Months 6, 12, and 24

    Measured: At baseline, Month 6, 12, and 24

  9. Change of NYHA/WHO PH functional class from baseline to Months 6, 12, and 24

    NYHA: New York Heart Association WHO: World Health Organization

    Measured: At baseline, Month 6, 12, and 24

Secondary outcomes (7)

  1. Change from baseline to Month 6 and change from baseline to Month 12 in Borg Dysponea Index

    Measured: At baseline, Month 6 and Month 12

  2. Change from baseline to Month 6 and change from baseline to Month 12 in emPHasis-10

    Measured: At baseline, Month 6 and Month 12

  3. Persistence/discontinuation rates for riociguat

    Measured: Up to 24 months

  4. Reasons for discontinuation of riociguat

    Measured: At Month 6, 12, and 24 post-baseline

  5. Real-world treatment patterns for riociguat for PAH

    Measured: Up to 24 months

  6. Demographic of patients treated with riociguat

    Measured: Up to 24 months

  7. Clinical characteristics of patients treated with riociguat

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2021
  2. Study start16 Jul 2021
  3. Primary completion19 Oct 2024
  4. Study completion3 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04813926
Sponsor's protocol ID
21427
Acronym
ROAR
Status last verified
Feb 2025
First submitted
22 Mar 2021
Last updated
10 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Arterial Hypertension, run by Bayer at 50 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (AEs) and serious adverse events (SAEs) (time frame: Up to 24 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04813926.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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