Trial Condition(s):

Pulmonary arterial hypertension

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)

Bayer Identifier:

21427

ClinicalTrials.gov Identifier:

NCT04813926

EudraCT Number:

Not Available

Recruiting

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.

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:
a. Blinded clinical trial
b. Clinical trial involving an unapproved drug
c. 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

Trial Summary

Enrollment Goal
500
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Beaumont Hospital

Troy, United States, 48085

Status
Not yet recruiting
 
Locations

Baylor Scott and White

Plano, United States, 75093

Status
Recruiting
 
Locations

UCSF

Fresno, United States, 93710

Status
Not yet recruiting
 
Locations

Columbia

New York, United States, 10032

Status
Not yet recruiting
 
Locations

St Francis Medical Ctr

Columbus, United States, 31904

Status
Not yet recruiting
 
Locations

Winthrop

Mineola, United States, 11501

Status
Not yet recruiting
 
Locations

Advocate Christ

Oak Lawn, United States, 60453

Status
Recruiting
 
Locations

University of Cincinnati

Cincinnati, United States, 45220

Status
Recruiting
 
Locations

USC

Los Angeles, United States, 90089

Status
Not yet recruiting
 
Locations

Banner University Medical Center- Phoenix

Phoenix, United States, 85006

Status
Not yet recruiting
 
Locations

VCU/MCV

Richmond, United States, 23219

Status
Recruiting
 
Locations

Froedtert/Medical College of Wisconsin

Milwaukee, United States, 53226

Status
Not yet recruiting
 
Locations

Richmond Pulmonary Associates

Richmond, United States, 23219

Status
Not yet recruiting
 
Locations

Integris

Oklahoma City, United States, 73112

Status
Not yet recruiting
 
Locations

Boston University

Boston, United States, 02215

Status
Recruiting
 
Locations

University of Rochester

Rochester, United States, 14642

Status
Not yet recruiting
 
Locations

Advent Health

Orlando, United States, 32808

Status
Recruiting
 
Locations

UNMH

Albuquerque, United States, 87114

Status
Not yet recruiting
 
Locations

University of Missouri

Columbia, United States, 30309

Status
Recruiting
 
Locations

St. Louis University

St. Louis, United States, 63103

Status
Not yet recruiting
 
Locations

Providence

Spokane, United States, 99208

Status
Recruiting
 
Locations

Loyola

Maywood, United States, 60153

Status
Recruiting
 
Locations

CCF (Cleveland Clinic Florida)

Weston, United States, 33331

Status
Not yet recruiting
 
Locations

Allegheny General Hospital

Pittsburgh, United States, 15212

Status
Recruiting
 
Locations

Tampa General Hospital USF

Tampa, United States, 33606

Status
Recruiting
 
Locations

Univ of Arizona College of Medicine, Tucson

Tucson, United States, 85719

Status
Recruiting
 
Locations

Advocate Aurora

Milwaukee, United States, 53215

Status
Recruiting
 
Locations

Mass General

Boston, United States, 02210

Status
Not yet recruiting
 
Locations

Santa Barbara Cottage Hospital

Santa Barbara, United States, 93105

Status
Recruiting
 
Locations

Houston Methodist

Houston, United States, 77030

Status
Recruiting
 
Locations

Honor Health

Phoenix, United States, 85020

Status
Not yet recruiting
 
Locations

Legacy Health

Portland, United States, 97232

Status
Recruiting
 
Locations

UT Southwestern

Dallas, United States, 75390

Status
Not yet recruiting
 
Locations

UC Davis

Sacramento, United States, 95817

Status
Not yet recruiting
 
Locations

NYU Langone

New York, United States, 10016

Status
Not yet recruiting
 
Locations

Northwell Health

New Hyde Park, United States, 11042

Status
Recruiting
 
Locations

Mount Sinai

New York, United States, 10003

Status
Not yet recruiting
 
Locations

Temple University

Philadelphia, United States, 19140

Status
Not yet recruiting
 
Locations

UC Irvine

Irvine, United States, 92697

Status
Recruiting
 
Locations

Alliance Pulmonary

Guaynabo, United States, 00968

Status
Recruiting
 
Locations

Barnes / Wash U

St. Louis, United States, 63108

Status
Not yet recruiting
 
Locations

Northwestern

Chicago, United States, 60611

Status
Recruiting
 
Locations

Seton Heart

Austin, United States, 78759

Status
Recruiting
 
Locations

Cedar Sinai

Los Angeles, United States, 90048

Status
Recruiting
 
Locations

Premier Pulmonary

Denison, United States, 75020

Status
Recruiting
 
Locations

Norton Pulmonary Specialists

Louisville, United States, 40202

Status
Recruiting
 
Locations

UCSD

San Diego, United States, 92103

Status
Recruiting
 
Locations

AnMed Health Medical Center

Anderson, United States, 29621

Status
Recruiting
 
Locations

KUMC

Kansas City, United States, 66160

Status
Recruiting
 
Locations

UNMC

Omaha, United States, 68198

Status
Recruiting
 

Trial Design