A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Sotatercept in Adults With Combined Postcapillary and Precapillary Pulmonary Hypertension (CpcPH) and Heart Failure With Preserved Ejection Fraction (HFpEF)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 352
- 主要终点
- Time to Clinical Worsening (TTCW)
研究概览
简要总结
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.
详细描述
Participants will have the option to continue or start treatment with sotatercept in the extension study, MK-7962-023 (NCT06814145), after completing the End of Treatment visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •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
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •Has a diagnosis of PH in World Health Organization Group 1, 3, 4, or 5
- •Has CV comorbidities:
- •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
- •History of hypertrophic cardiomyopathy, infiltrative cardiomyopathy (including, but not limited to, cardiac amyloidosis), dilated cardiomyopathy, arrhythmogenic ventricular cardiomyopathy, or restrictive cardiomyopathy
- •History or evidence of chronic liver disease
- •Has a current diagnosis of end-stage renal disease
- •History of organ transplantation (except corneal transplant) or bone marrow transplantation ≤5 years before Screening or has a life expectancy of <12 months
- •History of malignancy ≤5 years before Screening, with the exception of fully excised or treated basal cell carcinoma, cervical carcinoma in situ, or ≤2 squamous cell carcinomas of the skin
- •Has any noncardiopulmonary condition or acute/chronic impairment(s) (other than dyspnea) that limits their ability to perform the 6-minute walk test
- •Has moderate or severe obstructive sleep apnea
- •Has a body mass index ≥50 kg/m^2
- •Has been treated with any approved pulmonary arterial hypertension-specific medications within 30 days of Randomization
- •Has background medication with the following agents: sodium-glucose cotransporter-2 inhibitor, renin-angiotensin-aldosterone system inhibitors, mineralocorticoid receptor antagonists, diuretics, and beta-blockers, that is not a stable dose for ≥30 days before Randomization
研究组 & 干预措施
Placebo
Participants will receive matching placebo via SC injection every 3 weeks until end of study (up to approximately 37 months).
干预措施: Placebo (Biological)
Sotatercept
Participants will receive sotatercept via subcutaneous (SC) injection every 3 weeks at an initial dose of 0.3 mg/kg until end of study (up to approximately 37 months).
干预措施: Sotatercept (Biological)
结局指标
主要结局
Time to Clinical Worsening (TTCW)
时间窗: Up to ~37 weeks
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.
次要结局
- Time to First Event of CV Death, Hospitalization Due to Worsening HF or PH, or Urgent Visit Due to Worsening HF or PH(Up to ~37 weeks)
- Time to First Event of CV Death or Hospitalization Due to Worsening HF or PH(Up to ~37 weeks)
- Change From Baseline in 6MWD at Week 24(Baseline and Week 24)
- Time to the Date of Death Due to Any Cause(Up to ~37 weeks)
- Time to First Hospitalization Due to Worsening HF or PH(Up to ~37 weeks)
- Time to First Urgent Visit Due to Worsening HF or PH(Up to ~37 weeks)
- Percentage of Participants Maintaining and/or Improving New York Heart Association (NYHA) Functional Class (FC) at Week 24(Week 24)
- Change From Baseline in N-Terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Levels at Week 24(Baseline and Week 24)
- Number of Participants Who Experience One or More Adverse Events (AEs)(Up to ~37 weeks)
- Number of Participants Who Discontinue Study Intervention Due to an AE(Up to ~37 weeks)
- Time to CV Death(Up to ~37 weeks)