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.
This is an extension study for studies MK-7962-007 (NCT04945460) and MK-7962-041 (NCT number pending). Following protocol amendment 3, all participants in the Sotatercept 0.7 mg/kg arm will switch to the Sotatercept 0.3 mg/kg arm, and new participants will only enroll in the Sotatercept 0.3 mg/kg arm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
440
subcutaneous injection
Pulmonary Associates, PA ( Site 1008)
Phoenix, Arizona, United States
Scripps Clinic John R Anderson V Medical Pavillion ( Site 1004)
La Jolla, California, 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
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 10 years
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 10 years
Change From Parent Study Baseline in Pulmonary Vascular Resistance (PVR) at 6 Months Following Enrollment in the Extension
PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization (RHC). The change from baseline in PVR at Month 6 will be presented. Per protocol, baseline was defined as the baseline data collected for each participant at the time of their enrollment on one of the parent studies.
Time frame: Baseline and Month 6
Change From Baseline in the 6-Minute Walk Distance (6MWD) at 6 Months Following Enrollment in the Extension
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Month 6 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Time frame: Baseline and Month 6
Change From Baseline in the 6MWD at 12 Months Following Enrollment in the Extension
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Month 12 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Time frame: Baseline and Month 12
Change From Baseline in the 6MWD at 18 Months Following Enrollment in the Extension
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Month 18 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Time frame: Baseline and Month 18
Change From Baseline in the 6MWD at End of Treatment
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at the time of treatment discontinuation will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Time frame: Baseline and up to approximately 43.5 months
Change From Baseline in New York Heart Association Functional Class (NYHA FC) at 6 Months Following Enrollment in the Extension
NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Month 6 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Time frame: Baseline and Month 6
Change From Baseline in NYHA FC at 12 Months Following Enrollment in the Extension
NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Month 12 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Time frame: Baseline and Month 12
Change From Baseline in NYHA FC at 18 Months Following Enrollment in the Extension
NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Month 18 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Time frame: Baseline and Month 18
Change From Baseline in NYHA FC at End of Treatment
NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at the time of treatment discontinuation will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Time frame: Baseline and up to approximately 10 years
Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) at 6 Months Following Enrollment in the Extension
NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. The change from baseline in NT-proBNP at Month 6 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Time frame: Baseline and Month 6
Change From Baseline in NT-proBNP at 12 Months Following Enrollment in the Extension
NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. The change from baseline in NT-proBNP at Month 12 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Time frame: Baseline and Month 12
Change From Baseline in NT-proBNP at 18 Months Following Enrollment in the Extension
NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. The change from baseline in NT-proBNP at Month 18 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Time frame: Baseline and Month 18
Change From Baseline in NT-proBNP at End of Treatment
NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. The change from baseline in NT-proBNP at the time of treatment discontinuation will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Time frame: Baseline and up to approximately 10 years
Change From Parent Study Week 24 in PVR at 6 Months Following Enrollment in the Extension for Placebo Participants
PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization (RHC). The change from parent study Week 24 in PVR at Month 6 will be presented. Per protocol, baseline was defined as the value collected at Week 24 of the parent study.
Time frame: Baseline and Month 6
Change From Baseline in 6MWD at 6 Months Following Enrollment in the Extension for Placebo Participants
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Month 6 will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension.
Time frame: Baseline and Month 6
Change From Baseline in 6MWD at 12 Months Following Enrollment in the Extension for Placebo Participants
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Month 12 will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension.
Time frame: Baseline and Month 12
Change From Baseline in 6MWD at 18 Months Following Enrollment in the Extension for Placebo Participants
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Month 18 will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension.
Time frame: Baseline and Month 18
Change From Baseline in 6MWD at End of Treatment for Placebo Participants
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at the time of treatment discontinuation will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension.
Time frame: Baseline and up to approximately 43.5 months
Change From Baseline in NYHA FC at 6 Months Following Enrollment in the Extension for Placebo Participants
NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Month 6 will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension.
Time frame: Baseline and Month 6
Change From Baseline in NYHA FC at 12 Months Following Enrollment in the Extension for Placebo Participants
NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Month 12 will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension.
Time frame: Baseline and Month 12
Change From Baseline in NYHA FC at 18 Months Following Enrollment in the Extension for Placebo Participants
NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Month 18 will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension.
Time frame: Baseline and Month 18
Change From Baseline in NYHA FC at End of Treatment for Placebo Participants
NYHA FC classifies the extent of heart failure. The change from extension baseline in NYHA FC at the time of treatment discontinuation will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension.
Time frame: Baseline and up to approximately 10 years
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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
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