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)
Merck Sharp & Dohme LLC
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- BiologicalSotatercept
subcutaneous injection
Locations (56)
- Pulmonary Associates, PA ( Site 1008)Phoenix, Arizona
- Jeffrey S. Sager, MD Medical Corporation ( Site 1060)Santa Barbara, California
- Stanford University Medical Center ( Site 1024)Stanford, California
- South Denver Cardiology Associates ( Site 1091)Littleton, Colorado
- Yale New Haven Hospital ( Site 1093)New Haven, Connecticut
- AdventHealth Orlando ( Site 1058)Orlando, Florida