2022-500881-80-00已完成3 期
A Pivotal Phase 3 Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of the sGC Stimulator Vericiguat/MK-1242 in Adults With Chronic Heart Failure With Reduced Ejection Fraction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,214
- 试验地点
- 134
- 主要终点
- Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization
研究概览
简要总结
To evaluate the efficacy of vericiguat compared with placebo on reducing the risk of cardiovascular death or heart failure hospitalization.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •History of chronic HF [New York Heart Association (NYHA) Class II to IV] on guideline-directed medical therapy for heart failure (GDMT) with no HF hospitalization within 6 months or outpatient IV diuretic use within 3 months before randomization.
- •Left ventricular ejection fraction (LVEF) of ≤40%, assessed within 12 months before randomization by any imaging method.
- •Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.
- •A female participant is eligible to participate if she is not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP), or is a WOCBP and agrees to follow contraceptive guidance during the study intervention period and for at least 1 month after the last dose of study intervention.
排除标准
- •Has SBP <100 mm Hg or symptomatic hypotension.
- •History of symptomatic carotid stenosis, transient ischemic attack (TIA), or stroke within 3 months before randomization.
- •Malignancy or other noncardiac condition limiting life expectancy to <3 years.
- •Requires continuous home oxygen for severe pulmonary disease.
- •Interstitial lung disease.
- •Discontinuation or dose modification of GDMT or vericiguat within 4 weeks before randomization.
- •Recent history (within the last year) of drug or alcohol abuse or dependence.
- •Awaiting heart transplantation, is receiving continuous IV infusion of an inotrope, or has or anticipates receiving an implanted ventricular assist device.
- •Amyloidosis or sarcoidosis.
- •Primary valvular heart disease requiring surgical procedure or intervention or has undergone a valvular surgical procedure or intervention within 3 months before randomization.
- •Hypertrophic cardiomyopathy.
- •Acute myocarditis or Takotsubo cardiomyopathy.
- •History of heart transplant.
- •Tachycardia-induced cardiomyopathy and/or uncontrolled tachyarrhythmia.
- •Acute coronary syndrome, or undergone coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within 3 months before randomization.
结局指标
主要结局
Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization
Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization
次要结局
- Time to First Occurrence of CV Death
- Time to First Occurrence of HF Hospitalization
- Time to Total HF Hospitalizations (Including First and Recurrent Events)
- Time to First Occurrence of Composite Endpoint of All-Cause Mortality or HF Hospitalization
- Time to All-Cause Mortality
- Percentage of Participants who Experienced One or More Selected Nonserious Adverse Events (NSAE)
- Percentage of Participants Who Experienced One or More Serious Adverse Events (SAE)
- Percentage of Participants Who Experienced One or More Events of Clinical Interest (ECI)
研究者
Ciaran Joseph McMullan
Scientific
Merck Sharp & Dohme LLC
研究点 (134)
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