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RECRUITINGPhase 2INTERVENTIONAL

Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023)

A Phase 2, Multicenter, Double-blind, Extension Study to Evaluate the Effects of Sotatercept for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) Due to Heart Failure With Preserved Ejection Fraction (HFpEF)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Researchers are looking for new ways to treat people with a type of pulmonary hypertension called combined postcapillary and precapillary pulmonary hypertension (Cpc-PH). This study focuses on Cpc-PH that is caused by heart failure with preserved ejection fraction (HFpEF). Researchers want to know if the study treatment, sotatercept, can treat people with Cpc-PH caused by HFpEF. This is an extension study, which means people who took part in a certain study on sotatercept for Cpc-PH (called a parent study) may be able to join this study. In this extension study, people will take sotatercept and researchers will follow their health for a longer time. The main goal of this extension study is to learn about the long-term safety of sotatercept and if people tolerate it over a longer period of time.

Who May Be Eligible (Plain English)

Who May Qualify: The main inclusion criteria include but are not limited to the following: \- Completed MK-7962-007 (CADENCE) (Visit 9 and end of treatment \[EOT\] visit) without discontinuing study intervention and is able to safely enroll into MK-7962-007 (HARMONIZE) Who Should NOT Join This Trial: The main exclusion criteria include but are not limited to the following: - Has a diagnosis of pulmonary hypertension (PH) in world health organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5 - Has had a study intervention interruption - Is pregnant or breastfeeding - Has chronic liver disease with severe hepatic impairment and/or cirrhosis (eg, hepatic encephalopathy) - Anticipation of more than 1 valve replacement or repair (mechanical or biomechanical) and/or have undergone more than 1 valve replacement or repair - Has severe tricuspid regurgitation due to primary valvular disease (eg, from endocarditis, carcinoid, or mechanical destruction) - Anticipated or undergone heart transplant or ventricular assist device implantation - Has had prior exposure to luspatercept Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: \- Completed MK-7962-007 (CADENCE) (Visit 9 and end of treatment \[EOT\] visit) without discontinuing study intervention and is able to safely enroll into MK-7962-007 (HARMONIZE) Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a diagnosis of pulmonary hypertension (PH) in world health organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5 * Has had a study intervention interruption * Is pregnant or breastfeeding * Has chronic liver disease with severe hepatic impairment and/or cirrhosis (eg, hepatic encephalopathy) * Anticipation of more than 1 valve replacement or repair (mechanical or biomechanical) and/or have undergone more than 1 valve replacement or repair * Has severe tricuspid regurgitation due to primary valvular disease (eg, from endocarditis, carcinoid, or mechanical destruction) * Anticipated or undergone heart transplant or ventricular assist device implantation * Has had prior exposure to luspatercept

Treatments Being Tested

BIOLOGICAL

Sotatercept

subcutaneous injection

Locations (20)

Pulmonary Associates, PA ( Site 1008)
Phoenix, Arizona, United States
Jeffrey S. Sager, MD Medical Corporation ( Site 1060)
Santa Barbara, California, United States
Stanford University Medical Center ( Site 1024)
Stanford, California, United States
South Denver Cardiology Associates ( Site 1091)
Littleton, Colorado, United States
Yale New Haven Hospital ( Site 1093)
New Haven, Connecticut, United States
AdventHealth Orlando ( Site 1058)
Orlando, Florida, United States
The Emory Clinic ( Site 1030)
Atlanta, Georgia, United States
Norton Pulmonary Specialists ( Site 1066)
Louisville, Kentucky, United States
University Of Nebraska Medical Center ( Site 1053)
Omaha, Nebraska, United States
Weill Cornell Medical Center ( Site 1046)
New York, New York, United States
Duke University Medical Center ( Site 1026)
Durham, North Carolina, United States
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation. ( Site 1065)
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center ( Site 1032)
Columbus, Ohio, United States
Allegheny General Hospital ( Site 1088)
Pittsburgh, Pennsylvania, United States
Lankenau Medical Center ( Site 1089)
Wynnewood, Pennsylvania, United States
Rhode Island Hospital ( Site 1039)
Providence, Rhode Island, United States
Medical University of South Carolina ( Site 1003)
Charleston, South Carolina, United States
Statcare Pulmonary Consultants ( Site 1031)
Knoxville, Tennessee, United States
Intermountain Medical Center ( Site 1079)
Murray, Utah, United States