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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
130
subcutaneous injection
Pulmonary Associates, PA ( Site 1008)
Phoenix, Arizona, United States
ACTIVE_NOT_RECRUITINGJeffrey S. Sager, MD Medical Corporation ( Site 1060)
Santa Barbara, California, United States
ACTIVE_NOT_RECRUITINGStanford University Medical Center ( Site 1024)
Stanford, California, United States
ACTIVE_NOT_RECRUITINGSouth Denver Cardiology Associates ( Site 1091)
Littleton, Colorado, United States
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Time frame: Up to approximately 187 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Time frame: Up to approximately 168 weeks
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 48
PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization (RHC). The change from baseline in PVR at Week 48 will be presented.
Time frame: Baseline and Week 48
Change From Baseline in the 6-Minute Walk Distance (6MWD) at Week 48
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Week 48 will be presented.
Time frame: Baseline and Week 48
Change From Baseline in the 6MWD at Week 126
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Week 126 will be presented.
Time frame: Baseline and Week 126
Change From Baseline in the 6MWD at Week 174
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Week 174 will be presented.
Time frame: Baseline and Week 174
Change From Baseline in New York Heart Association Functional Class (NYHA FC) at Week 48
NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Week 48 will be presented.
Time frame: Baseline and Week 48
Change From Baseline in NYHA FC at Week 126
NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Week 126 will be presented.
Time frame: Baseline and Week 126
Change From Baseline in NYHA FC at Week 174
NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Week 174 will be presented.
Time frame: Baseline and Week 174
Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) at Week 48
NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. NT-proBNP will be measured at baseline and at Week 48. The change from baseline in NT-proBNP at Week 48 will be presented.
Time frame: Baseline and Week 48
Change From Baseline in NT-proBNP at Week 126
NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. NT-proBNP will be measured at baseline and at Week 126. The change from baseline in NT-proBNP at Week 126 will be presented.
Time frame: Baseline and Week 126
Change From Baseline in NT-proBNP at Week 174
NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. NT-proBNP will be measured at baseline and at Week 174. The change from baseline in NT-proBNP at Week 174 will be presented.
Time frame: Baseline and Week 174
Change From Week 24 in PVR at Week 48
PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization (RHC). The change from Week 24 in PVR at Week 48 will be presented.
Time frame: Week 24 and Week 48
Change From Week 24 in 6MWD at Week 48
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from Week 24 in 6MWD at Week 48 will be presented.
Time frame: Week 24 and Week 48
Change From Week 24 in NYHA FC at Week 48
NYHA FC classifies the extent of heart failure. The change from Week 24 in NYHA FC at Week 48 will be presented.
Time frame: Week 24 and Week 48
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Yale New Haven Hospital ( Site 1093)
New Haven, Connecticut, United States
ACTIVE_NOT_RECRUITINGAdventHealth Orlando ( Site 1058)
Orlando, Florida, United States
ACTIVE_NOT_RECRUITINGThe Emory Clinic ( Site 1030)
Atlanta, Georgia, United States
RECRUITINGNorton Pulmonary Specialists ( Site 1066)
Louisville, Kentucky, United States
ACTIVE_NOT_RECRUITINGUniversity Of Nebraska Medical Center ( Site 1053)
Omaha, Nebraska, United States
ACTIVE_NOT_RECRUITINGWeill Cornell Medical Center ( Site 1046)
New York, New York, United States
ACTIVE_NOT_RECRUITING...and 46 more locations