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Clinical Trial Number: HARMONIZE
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Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023)

Study ID: HARMONIZE
Phase II
Physician Investigator(s)
Study Locations

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484.476.8558
EppsH@mlhs.org

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.

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Eligibility Criteria

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