A Prospective, Observational, Single-arm Study to Evaluate the Efficacy and Safety of Vericiguat in Patients With Chronic Kidney Disease and Heart Failure.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Left ventricular ejection fraction (LVEF)
研究概览
简要总结
Chronic Kidney Disease often requires dialysis and other treatments to sustain life, and patients frequently suffer from heart failure, which exacerbates the disease burden. Research has shown that the incidence of heart failure is high among patients on dialysis, and the prognosis is poor. In recent years, there has been significant progress in the treatment of heart failure. Vericiguat, a novel sGC stimulator, can improve cardiac function and exercise tolerance, reduce the risk of cardiovascular death and hospitalization for heart failure, and has good tolerance. It has been included in relevant guidelines as a recommended drug. It has good tolerance in patients with renal insufficiency, and its therapeutic effect is consistent in patients with different levels of eGFR. However, there is a lack of prospective, randomized controlled studies targeting the special population of patients on dialysis. This study is a prospective, observational, single-arm study, planning to recruit 118 patients from June 2025 to June 2026. It aims to assess the efficacy and safety of Vericiguat in patients with heart failure on hemodialysis, to provide new evidence-based medical evidence for the treatment of heart failure in this special population, optimize the treatment strategy, and improve the prognosis and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •The patient is aged between 18 and 80 years
- •Suffering from chronic kidney disease (eGFR<90ml/min/1.73m², by CKD-EPI formula).
- •They have chronic heart failure (NYHA class ≥II), with reduced ejection fraction, defined as LVEF≤50%.
- •Their serum potassium level has been ≤4.8 mmol/L in the past month.
- •For women of childbearing potential, the pregnancy test result is negative at the screening visit and they agree.
- •Adequate contraceptive measures are taken.
- •The patient's dialysis adequacy assessment has reached Kt/V >1.2, or URR>70%.
- •The study protocol is implemented after being approved by the hospital ethics committee, and all patients voluntarily participate in this study
排除标准
- •Acute renal failure.
- •Systolic blood pressure below 90 mmHg at screening (systolic blood pressure less than 95 mmHg during interdialytic period).
- •Isolated right heart failure due to pulmonary disease; the primary cause of dyspnea is due to non-cardiac, non-heart failure reasons, such as acute or chronic respiratory diseases.
- •History of myocardial infarction or cerebrovascular event within the past 3 months.
- •History of angioedema.
- •Hemodialysis patients with dialysis frequency less than 3 times per week.
- •Significant laboratory abnormalities at screening that interfere with the assessment of the safety or efficacy of the study drug (e.g., serum potassium > 5.5 mmol/L or < 3.5 mmol/L, serum sodium < 130 mmol/L, or alanine aminotransferase or aspartate aminotransferase > 2 times the upper limit of the normal range).
- •History of kidney transplantation or planned kidney transplantation within the next 12 months.
- •Use of medications for pulmonary arterial hypertension, such as sildenafil, during the study period.
- •Known allergy to the study treatment (active substance or excipients).
- •Any other disease or treatment that makes the patient ineligible to participate in this study or to complete the entire planned study period (e.g., active malignancy or other diseases that limit life expectancy to less than 12 months).
- •Pregnant or breastfeeding during the study period, or intending to become pregnant.
研究组 & 干预措施
Vericiguat
Under the premise of ensuring safety, treat with a stable dose of Vericiguat 2.5mg PO QD for 2 weeks. After 2 weeks, increase the dose to 5mg PO QD. If blood pressure elevation occurs during the operation phase, the researchers suggest titrating or starting additional antihypertensive drugs, with a follow-up of 12 months. If the patient has tolerability issues (symptomatic hypotension or SBP<90 mmHg), the dose should be reduced or discontinued.
干预措施: Vericiguat (Drug)
结局指标
主要结局
Left ventricular ejection fraction (LVEF)
时间窗: 12weeks
Change from baseline in left ventricular ejection fraction (LVEF) between baseline and end of study
Left ventricular ejection fraction(LVEF)
时间窗: 12weeks
Change from baseline in left ventricular ejection fraction(LVEF)between baseline and end of study
次要结局
- Minnesota Heart Failure Quality of Life Questionnaire (LiHFe)(12 weeks)
- Electrocardiogram(ECG)(12 weeks)
- Systolic and diastolic blood pressure(12 weeks)
- Estimated glomerular filtration rate(eGFR)(12 weeks)
- N terminal proB type natriuretic peptide (NT-prpBNP)(12 weeks)
- The ratio of mitral early diastolic blood flow peak and mitral annulus velocity (E/E')(12 weeks)
- Concentration of high-sensitivity serum troponin T(12 weeks)
- Left ventricular end diastolic volume (LVEDV)(12 weeks)
- Left atrial volume (LAV)(12 weeks)
- Pulmonary Artery Pressure(12 weeks)
研究者
ShuangXin Liu
Chief Physician
Guangdong Provincial People's Hospital