Comparing the Efficacy and Safety of Vericiguat With Standard Medical Treatment in Patients With Heart Failure and Reduced Ejection Fraction: Randomized, Placebo-controlled, Parallel-group, Double-blind Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 500
- 主要终点
- Quality of life using Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
研究概览
简要总结
To compare the effectiveness and safety of Vericiguat with Standard Medical Treatment in Patients with Heart Failure and Reduced Ejection Fraction
详细描述
Heart failure with reduced ejection fraction (HFrEF) remains a major cause of morbidity, mortality, and healthcare utilization despite advances in guideline-directed medical therapy. Patients who experience worsening heart failure events, including hospitalization or the need for urgent outpatient treatment, remain at increased risk of recurrent cardiovascular events and represent a high-risk population requiring additional therapeutic strategies.
The nitric oxide-soluble guanylate cyclase (NO-sGC)-cyclic guanosine monophosphate (cGMP) pathway plays an important role in maintaining cardiovascular function. In heart failure, endothelial dysfunction and reduced nitric oxide bioavailability may impair this pathway, contributing to vascular dysfunction, myocardial remodeling, and disease progression.
Vericiguat is an oral soluble guanylate cyclase stimulator that enhances cGMP production by directly stimulating soluble guanylate cyclase and increasing its sensitivity to endogenous nitric oxide. This mechanism provides a novel therapeutic approach that differs from conventional heart failure treatments targeting neurohormonal pathways.
Previous clinical evidence, including the VICTORIA trial, demonstrated that vericiguat reduced the risk of cardiovascular death or first hospitalization for heart failure among patients with chronic heart failure and recent worsening heart failure events. However, further evaluation of its effectiveness and safety in specific clinical settings and populations remains important.
This randomized, placebo-controlled, double-blind clinical trial will evaluate the effectiveness and safety of vericiguat in patients with heart failure with reduced ejection fraction receiving standard medical therapy. The study aims to determine whether the addition of vericiguat provides further clinical benefit compared with standard therapy alone in this high-risk patient population.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years of any gender
- •Chronic heart failure (New York Heart Association [NYHA] functional class II, III, or IV), a reduced left ventricular ejection fraction of less than 45% within 12 months before randomization
- •Elevated natriuretic peptide level: (For patients in sinus rhythm, the criteria include a plasma B-type natriuretic peptide (BNP) level of at least 300 pg per milliliter or an NT-proBNP level of at least 1000 pg per milliliter. For patients in atrial fibrillation, the criteria included a BNP level of at least 500 pg per milliliter or an NT-proBNP level of at least 1600 pg per milliliter).
- •Evidence of worsening heart failure.
- •The percentage of enrolled patients with an estimated glomerular filtration rate of 15 to 30 ml per minute per 1.73 m2 of body-surface area was capped at 15%.
- •Patients on guideline-based medical therapy 3 months
- •Written and informed consent.
排除标准
- •Systolic blood pressure of less than 100 mm Hg.
- •Concurrent or anticipated use of long-acting nitrates.
- •Use of intravenous inotropes or implantable left ventricular assist devices.
- •Not on standard of care medical treatment for heart failure.
- •Unwillingness to give consent
研究组 & 干预措施
Placebo
Standard of care medications with placebo.
干预措施: Placebo (Drug)
Treatment
Vericiguat 10 mg (titrated from 2.5 mg, to 5 mg, and to 10 mg), on a background of standard of care
干预措施: Vericiguat tablet (Drug)
结局指标
主要结局
Quality of life using Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
时间窗: Baseline to Month 6
The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated, patient-reported instrument that assesses health status, including symptoms, physical limitations, social limitations, and quality of life in patients with heart failure. The Overall Summary Score ranges from 0 to 100, with higher scores indicating better health status. The primary endpoint is the change in the KCCQ-12 Overall Summary Score from baseline to Month 6.
次要结局
- First Hospitalization for Heart Failure(From enrollment to Month 6)