Researchers are looking for other ways to treat people with combined postcapillary and precapillary pulmonary hypertension (CpcPH). This trial focuses on CpcPH that is related to heart failure with preserved ejection fraction (HFpEF). The goal of the study is to learn if participants who receive sotatercept live longer without their CpcPH-HFpEF getting worse than those who receive placebo.
Has clinical diagnosis of HF with preserved ejection fraction on optimized guideline-directed medical therapy
Has CpcPH confirmed by right-heart catheterization
Has NYHA FC II or III
Has a diagnosis of PH in World Health Organization Group 1, 3, 4, or 5
History of surgical or transcatheter correction of mitral or aortic stenosis or regurgitation within 12 months before Screening
More than one valve replacement or repair (mechanical or bioprosthetic), or anticipated valve replacement or repair during the study
History of serious, life-threatening, or hemodynamically significant arrhythmia, long corrected QT interval syndrome, or Brugada syndrome
Parallel
Sotatercept
Biological/VaccineSC injection administered every 3 weeks.
Placebo
Biological/VaccineSC injection administered every 3 weeks.
Time to Clinical Worsening (TTCW)
TTCW was defined as time to first occurrence of any of the following events: cardiovascular (CV) death, hospitalization due to worsening heart failure (HF) or pulmonary hypertension (PH), urgent visits due to worsening HF or PH, or deterioration in exercise capacity (≥15% decrease from baseline in 6-minute walk distance \[6MWD\], confirmed by 2 tests) due to worsening HF or PH. CV deaths are defined as any deaths with a primary CV cause, including acute myocardial infarction (MI), sudden cardiac death, HF, PH worsening, stroke, and other CV causes.
Time to First Event of CV Death, Hospitalization Due to Worsening HF or PH, or Urgent Visit Due to Worsening HF or PH
CV deaths are defined as any deaths with a primary CV cause, including acute MI, sudden cardiac death, HF, PH worsening, stroke, and other CV causes. The time to first event of CV death, hospitalization due to worsening HF or PH, or urgent visit due to worsening HF or PH will be presented.
Time to First Event of CV Death or Hospitalization Due to Worsening HF or PH
CV deaths are defined as any deaths with a primary CV cause, including acute MI, sudden cardiac death, HF, PH worsening, stroke, and other CV causes. The time to first event of CV death or hospitalization due to worsening HF or PH will be presented.
Change From Baseline in 6MWD at Week 24
The 6MWD tests the distance walked in 6 minutes as an assessment of exercise capacity. The baseline value for 6MWD is the average of the 2 values collected during Screening. The change from baseline in 6MWD at Week 24 will be presented.
Time to the Date of Death Due to Any Cause
The time to date of death (all causes) will be presented.
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