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)

Pulmonary Arterial Hypertension Clinical Trial

— ROAR  

Official title:

RiOciguAt UseRs Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04813926
• Other study ID #: 21427
• Status: Active, not recruiting
• Start date: July 16, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Riociguat (Adempas, BAY63-2521)
Follow clinical practice.

Locations

Country	Name	City	State
Puerto Rico	Alliance Pulmonary	Guaynabo
United States	UNMH	Albuquerque	New Mexico
United States	AnMed Health Medical Center	Anderson	South Carolina
United States	Seton Heart	Austin	Texas
United States	Boston University	Boston	Massachusetts
United States	Mass General	Boston	Massachusetts
United States	Northwestern	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	University of Missouri	Columbia	Missouri
United States	St Francis Medical Ctr	Columbus	Georgia
United States	UT Southwestern	Dallas	Texas
United States	Premier Pulmonary	Denison	Texas
United States	UCSF	Fresno	California
United States	Houston Methodist	Houston	Texas
United States	UC Irvine	Irvine	California
United States	KUMC	Kansas City	Kansas
United States	Cedar Sinai	Los Angeles	California
United States	USC	Los Angeles	California
United States	Norton Pulmonary Specialists	Louisville	Kentucky
United States	Loyola	Maywood	Illinois
United States	Advocate Aurora	Milwaukee	Wisconsin
United States	Froedtert/Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Winthrop	Mineola	New York
United States	Northwell Health	New Hyde Park	New York
United States	Columbia	New York	New York
United States	Mount Sinai	New York	New York
United States	NYU Langone	New York	New York
United States	Advocate Christ	Oak Lawn	Illinois
United States	Integris	Oklahoma City	Oklahoma
United States	UNMC	Omaha	Nebraska
United States	Advent Health	Orlando	Florida
United States	Temple University	Philadelphia	Pennsylvania
United States	Banner University Medical Center- Phoenix	Phoenix	Arizona
United States	Honor Health	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Baylor Scott and White	Plano	Texas
United States	Legacy Health	Portland	Oregon
United States	Richmond Pulmonary Associates	Richmond	Virginia
United States	VCU/MCV	Richmond	Virginia
United States	University of Rochester	Rochester	New York
United States	UC Davis	Sacramento	California
United States	Barnes / Wash U	Saint Louis	Missouri
United States	St. Louis University	Saint Louis	Missouri
United States	UCSD	San Diego	California
United States	Santa Barbara Cottage Hospital	Santa Barbara	California
United States	Providence	Spokane	Washington
United States	Tampa General Hospital USF	Tampa	Florida
United States	Beaumont Hospital	Troy	Michigan
United States	Univ of Arizona College of Medicine, Tucson	Tucson	Arizona
United States	CCF (Cleveland Clinic Florida)	Weston	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Xcenda, LLC

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs) and serious adverse events (SAEs)		Up to 24 months
Primary	Change of 6-minute walk distance (6MWD) from baseline to Months 6, 12, and 24		At baseline, Month 6, 12, and 24
Primary	Change of NT-proBNP from baseline to Months 6, 12, and 24	NT-proBNP: N-terminal pro-hormone B-type natriuretic peptide	At baseline, Month 6, 12, and 24
Primary	Change of BNP from baseline to Months 6, 12, and 24	BNP: B-type natriuretic peptide	At baseline, Month 6, 12, and 24
Primary	Change of clinical PAH scores from baseline to Months 6, 12, and 24		At baseline, Month 6, 12, and 24
Primary	Change of hemodynamic measurements from RHC from baseline to Months 6, 12, and 24	RHC: Right-heart catheterization	At baseline, Month 6, 12, and 24
Primary	Change of ECHO measurements from baseline to Months 6, 12, and 24	ECHO: Echocardiogram	At baseline, Month 6, 12, and 24
Primary	Change of laboratory tests from baseline to Months 6, 12, and 24		At baseline, Month 6, 12, and 24
Primary	Change of NYHA/WHO PH functional class from baseline to Months 6, 12, and 24	NYHA: New York Heart Association WHO: World Health Organization	At baseline, Month 6, 12, and 24
Secondary	Change from baseline to Month 6 and change from baseline to Month 12 in Borg Dysponea Index		At baseline, Month 6 and Month 12
Secondary	Change from baseline to Month 6 and change from baseline to Month 12 in emPHasis-10		At baseline, Month 6 and Month 12
Secondary	Persistence/discontinuation rates for riociguat		Up to 24 months
Secondary	Reasons for discontinuation of riociguat		At Month 6, 12, and 24 post-baseline
Secondary	Real-world treatment patterns for riociguat for PAH		Up to 24 months
Secondary	Demographic of patients treated with riociguat		Up to 24 months
Secondary	Clinical characteristics of patients treated with riociguat		Up to 24 months