check_circleStudy Completed

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)

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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
  • - 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
July 2021 - February 2025
Phase
Phase 4
Could I Receive a placebo
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Not yet recruiting
Beaumont HospitalTroy, 48085, United States
Recruiting
Baylor Scott and WhitePlano, 75093, United States
Not yet recruiting
UCSFFresno, 93710, United States
Not yet recruiting
ColumbiaNew York, 10032, United States
Not yet recruiting
St Francis Medical CtrColumbus, 31904, United States
Not yet recruiting
WinthropMineola, 11501, United States
Recruiting
Advocate ChristOak Lawn, 60453, United States
Recruiting
University of CincinnatiCincinnati, 45220, United States
Not yet recruiting
USCLos Angeles, 90089, United States
Not yet recruiting
Banner University Medical Center- PhoenixPhoenix, 85006, United States
Recruiting
VCU/MCVRichmond, 23219, United States
Not yet recruiting
Froedtert/Medical College of WisconsinMilwaukee, 53226, United States
Not yet recruiting
Richmond Pulmonary AssociatesRichmond, 23219, United States
Not yet recruiting
IntegrisOklahoma City, 73112, United States
Recruiting
Boston UniversityBoston, 02215, United States
Not yet recruiting
University of RochesterRochester, 14642, United States
Recruiting
Advent HealthOrlando, 32808, United States
Not yet recruiting
UNMHAlbuquerque, 87114, United States
Recruiting
University of MissouriColumbia, 30309, United States
Not yet recruiting
St. Louis UniversitySt. Louis, 63103, United States
Recruiting
ProvidenceSpokane, 99208, United States
Recruiting
LoyolaMaywood, 60153, United States
Not yet recruiting
CCF (Cleveland Clinic Florida)Weston, 33331, United States
Recruiting
Allegheny General HospitalPittsburgh, 15212, United States
Recruiting
Tampa General Hospital USFTampa, 33606, United States
Recruiting
Univ of Arizona College of Medicine, TucsonTucson, 85719, United States
Recruiting
Advocate AuroraMilwaukee, 53215, United States
Not yet recruiting
Mass GeneralBoston, 02210, United States
Recruiting
Santa Barbara Cottage HospitalSanta Barbara, 93105, United States
Recruiting
Houston MethodistHouston, 77030, United States
Not yet recruiting
Honor HealthPhoenix, 85020, United States
Recruiting
Legacy HealthPortland, 97232, United States
Not yet recruiting
UT SouthwesternDallas, 75390, United States
Not yet recruiting
UC DavisSacramento, 95817, United States
Not yet recruiting
NYU LangoneNew York, 10016, United States
Recruiting
Northwell HealthNew Hyde Park, 11042, United States
Not yet recruiting
Mount SinaiNew York, 10003, United States
Not yet recruiting
Temple UniversityPhiladelphia, 19140, United States
Recruiting
UC IrvineIrvine, 92697, United States
Recruiting
Alliance PulmonaryGuaynabo, 00968, United States
Not yet recruiting
Barnes / Wash USt. Louis, 63108, United States
Recruiting
NorthwesternChicago, 60611, United States
Recruiting
Seton HeartAustin, 78759, United States
Recruiting
Cedar SinaiLos Angeles, 90048, United States
Recruiting
Premier PulmonaryDenison, 75020, United States
Recruiting
Norton Pulmonary SpecialistsLouisville, 40202, United States
Recruiting
UCSDSan Diego, 92103, United States
Recruiting
AnMed Health Medical CenterAnderson, 29621, United States
Recruiting
KUMCKansas City, 66160, United States
Recruiting
UNMCOmaha, 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 24
    date_rangeTime Frame:
    At baseline, Month 6, 12, and 24
  • Change of NT-proBNP from baseline to Months 6, 12, and 24
    NT-proBNP: N-terminal pro-hormone B-type natriuretic peptide
    date_rangeTime Frame:
    At baseline, Month 6, 12, and 24
  • Change of BNP from baseline to Months 6, 12, and 24
    BNP: B-type natriuretic peptide
    date_rangeTime Frame:
    At baseline, Month 6, 12, and 24
  • Change of clinical PAH scores from baseline to Months 6, 12, and 24
    date_rangeTime Frame:
    At baseline, Month 6, 12, and 24
  • Change of hemodynamic measurements from RHC from baseline to Months 6, 12, and 24
    RHC: Right-heart catheterization
    date_rangeTime Frame:
    At baseline, Month 6, 12, and 24
  • Change of ECHO measurements from baseline to Months 6, 12, and 24
    ECHO: Echocardiogram
    date_rangeTime Frame:
    At baseline, Month 6, 12, and 24
  • Change of laboratory tests from baseline to Months 6, 12, and 24
    date_rangeTime Frame:
    At baseline, Month 6, 12, and 24
  • Change of NYHA/WHO PH functional class from baseline to Months 6, 12, and 24
    NYHA: New York Heart Association WHO: World Health Organization
    date_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 Index
    date_rangeTime Frame:
    At baseline, Month 6 and Month 12
  • Change from baseline to Month 6 and change from baseline to Month 12 in emPHasis-10
    date_rangeTime Frame:
    At baseline, Month 6 and Month 12
  • Persistence/discontinuation rates for riociguat
    date_rangeTime Frame:
    Up to 24 months
  • Reasons for discontinuation of riociguat
    date_rangeTime Frame:
    At Month 6, 12, and 24 post-baseline
  • Real-world treatment patterns for riociguat for PAH
    date_rangeTime Frame:
    Up to 24 months
  • Demographic of patients treated with riociguat
    date_rangeTime Frame:
    Up to 24 months
  • Clinical characteristics of patients treated with riociguat
    date_rangeTime Frame:
    Up to 24 months

Trial design

RiOciguAt UseRs Registry
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A