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)

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04813926
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bayer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Recruiting
Countries Puerto Rico, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Arterial Hypertension
Arms & Interventions

Arms

: Patients diagnosed with PAH

Interventions

Drug: - Riociguat (Adempas, BAY63-2521)

Follow clinical practice.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Phoenix, Arizona

Status

Not yet recruiting

Address

Banner University Medical Center- Phoenix

Phoenix, Arizona, 85006

Honor Health, Phoenix, Arizona

Status

Not yet recruiting

Address

Honor Health

Phoenix, Arizona, 85020

Tucson, Arizona

Status

Recruiting

Address

Univ of Arizona College of Medicine, Tucson

Tucson, Arizona, 85719

UCSF, Fresno, California

Status

Not yet recruiting

Address

UCSF

Fresno, California, 93710

UC Irvine, Irvine, California

Status

Recruiting

Address

UC Irvine

Irvine, California, 92697

Cedar Sinai, Los Angeles, California

Status

Recruiting

Address

Cedar Sinai

Los Angeles, California, 90048

USC, Los Angeles, California

Status

Not yet recruiting

Address

USC

Los Angeles, California, 90089

UC Davis, Sacramento, California

Status

Not yet recruiting

Address

UC Davis

Sacramento, California, 95817

UCSD, San Diego, California

Status

Recruiting

Address

UCSD

San Diego, California, 92103

Santa Barbara Cottage Hospital, Santa Barbara, California

Status

Recruiting

Address

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105

Advent Health, Orlando, Florida

Status

Recruiting

Address

Advent Health

Orlando, Florida, 32808

Tampa General Hospital USF, Tampa, Florida

Status

Recruiting

Address

Tampa General Hospital USF

Tampa, Florida, 33606

CCF (Cleveland Clinic Florida), Weston, Florida

Status

Not yet recruiting

Address

CCF (Cleveland Clinic Florida)

Weston, Florida, 33331

St Francis Medical Ctr, Columbus, Georgia

Status

Not yet recruiting

Address

St Francis Medical Ctr

Columbus, Georgia, 31904

Northwestern, Chicago, Illinois

Status

Recruiting

Address

Northwestern

Chicago, Illinois, 60611

Loyola, Maywood, Illinois

Status

Recruiting

Address

Loyola

Maywood, Illinois, 60153

Advocate Christ, Oak Lawn, Illinois

Status

Recruiting

Address

Advocate Christ

Oak Lawn, Illinois, 60453

KUMC, Kansas City, Kansas

Status

Recruiting

Address

KUMC

Kansas City, Kansas, 66160

Norton Pulmonary Specialists, Louisville, Kentucky

Status

Recruiting

Address

Norton Pulmonary Specialists

Louisville, Kentucky, 40202

Mass General, Boston, Massachusetts

Status

Not yet recruiting

Address

Mass General

Boston, Massachusetts, 02210

Boston University, Boston, Massachusetts

Status

Recruiting

Address

Boston University

Boston, Massachusetts, 02215

Beaumont Hospital, Troy, Michigan

Status

Not yet recruiting

Address

Beaumont Hospital

Troy, Michigan, 48085

University of Missouri, Columbia, Missouri

Status

Recruiting

Address

University of Missouri

Columbia, Missouri, 30309

St. Louis University, Saint Louis, Missouri

Status

Not yet recruiting

Address

St. Louis University

Saint Louis, Missouri, 63103

Barnes / Wash U, Saint Louis, Missouri

Status

Not yet recruiting

Address

Barnes / Wash U

Saint Louis, Missouri, 63108

UNMC, Omaha, Nebraska

Status

Recruiting

Address

UNMC

Omaha, Nebraska, 68198

UNMH, Albuquerque, New Mexico

Status

Not yet recruiting

Address

UNMH

Albuquerque, New Mexico, 87114

Winthrop, Mineola, New York

Status

Not yet recruiting

Address

Winthrop

Mineola, New York, 11501

Northwell Health, New Hyde Park, New York

Status

Recruiting

Address

Northwell Health

New Hyde Park, New York, 11042

Mount Sinai, New York, New York

Status

Not yet recruiting

Address

Mount Sinai

New York, New York, 10003

NYU Langone, New York, New York

Status

Not yet recruiting

Address

NYU Langone

New York, New York, 10016

Columbia, New York, New York

Status

Not yet recruiting

Address

Columbia

New York, New York, 10032

University of Rochester, Rochester, New York

Status

Not yet recruiting

Address

University of Rochester

Rochester, New York, 14642

University of Cincinnati, Cincinnati, Ohio

Status

Recruiting

Address

University of Cincinnati

Cincinnati, Ohio, 45220

Integris, Oklahoma City, Oklahoma

Status

Not yet recruiting

Address

Integris

Oklahoma City, Oklahoma, 73112

Legacy Health, Portland, Oregon

Status

Recruiting

Address

Legacy Health

Portland, Oregon, 97232

Temple University, Philadelphia, Pennsylvania

Status

Not yet recruiting

Address

Temple University

Philadelphia, Pennsylvania, 19140

Allegheny General Hospital, Pittsburgh, Pennsylvania

Status

Recruiting

Address

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212

AnMed Health Medical Center, Anderson, South Carolina

Status

Recruiting

Address

AnMed Health Medical Center

Anderson, South Carolina, 29621

Seton Heart, Austin, Texas

Status

Recruiting

Address

Seton Heart

Austin, Texas, 78759

UT Southwestern, Dallas, Texas

Status

Not yet recruiting

Address

UT Southwestern

Dallas, Texas, 75390

Premier Pulmonary, Denison, Texas

Status

Recruiting

Address

Premier Pulmonary

Denison, Texas, 75020

Houston Methodist, Houston, Texas

Status

Recruiting

Address

Houston Methodist

Houston, Texas, 77030

Baylor Scott and White, Plano, Texas

Status

Recruiting

Address

Baylor Scott and White

Plano, Texas, 75093

Richmond Pulmonary Associates, Richmond, Virginia

Status

Not yet recruiting

Address

Richmond Pulmonary Associates

Richmond, Virginia, 23219

VCU/MCV, Richmond, Virginia

Status

Recruiting

Address

VCU/MCV

Richmond, Virginia, 23219

Providence, Spokane, Washington

Status

Recruiting

Address

Providence

Spokane, Washington, 99208

Advocate Aurora, Milwaukee, Wisconsin

Status

Recruiting

Address

Advocate Aurora

Milwaukee, Wisconsin, 53215

Froedtert/Medical College of Wisconsin, Milwaukee, Wisconsin

Status

Not yet recruiting

Address

Froedtert/Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

International Sites

Alliance Pulmonary, Guaynabo, Puerto Rico

Status

Recruiting

Address

Alliance Pulmonary

Guaynabo, , 00968

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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