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)

NCT ID: NCT04813926

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-16
• Study Completion Date: 2025-02-03

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.

Conditions

Pulmonary Arterial Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients diagnosed with PAH

Riociguat (Adempas, BAY63-2521)

Intervention Type: DRUG

Follow clinical practice.

Interventions

Riociguat (Adempas, BAY63-2521)

Follow clinical practice.

Intervention Type: DRUG

Eligibility Criteria

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
• 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)
• Participating in any of the following:

1. Blinded clinical trial

2. Clinical trial involving an unapproved drug

3. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xcenda, LLC

UNKNOWN

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Banner University Medical Center- Phoenix

Phoenix, Arizona, United States

Honor Health

Phoenix, Arizona, United States

Univ of Arizona College of Medicine, Tucson

Tucson, Arizona, United States

UCSF

Fresno, California, United States

UC Irvine

Irvine, California, United States

Cedar Sinai

Los Angeles, California, United States

USC

Los Angeles, California, United States

UC Davis

Sacramento, California, United States

UCSD

San Diego, California, United States

Santa Barbara Cottage Hospital

Santa Barbara, California, United States

Advent Health

Orlando, Florida, United States

Tampa General Hospital USF

Tampa, Florida, United States

CCF (Cleveland Clinic Florida)

Weston, Florida, United States

St Francis Medical Ctr

Columbus, Georgia, United States

Northwestern

Chicago, Illinois, United States

Loyola

Maywood, Illinois, United States

Advocate Christ

Oak Lawn, Illinois, United States

KUMC

Kansas City, Kansas, United States

Norton Pulmonary Specialists

Louisville, Kentucky, United States

Mass General

Boston, Massachusetts, United States

Boston University

Boston, Massachusetts, United States

Beaumont Hospital

Troy, Michigan, United States

University of Missouri

Columbia, Missouri, United States

St. Louis University

St Louis, Missouri, United States

Barnes / Wash U

St Louis, Missouri, United States

UNMC

Omaha, Nebraska, United States

UNMH

Albuquerque, New Mexico, United States

Winthrop

Mineola, New York, United States

Northwell Health

New Hyde Park, New York, United States

Mount Sinai

New York, New York, United States

NYU Langone

New York, New York, United States

Columbia

New York, New York, United States

University of Rochester

Rochester, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

Integris

Oklahoma City, Oklahoma, United States

Legacy Health

Portland, Oregon, United States

Temple University

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

AnMed Health Medical Center

Anderson, South Carolina, United States

Seton Heart

Austin, Texas, United States

UT Southwestern

Dallas, Texas, United States

Premier Pulmonary

Denison, Texas, United States

Houston Methodist

Houston, Texas, United States

Baylor Scott and White

Plano, Texas, United States

Richmond Pulmonary Associates

Richmond, Virginia, United States

VCU/MCV

Richmond, Virginia, United States

Providence

Spokane, Washington, United States

Advocate Aurora

Milwaukee, Wisconsin, United States

Froedtert/Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Alliance Pulmonary

Guaynabo, , Puerto Rico

Countries

United States; Puerto Rico

Other Identifiers

21427

Identifier Type: -

Identifier Source: org_study_id