A Multicenter, Randomized, Controlled Trial to Evaluate the Efficacy and Safety of Perioperative Vericiguat in Patients Undergoing Cardiovascular Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of perioperative vericiguat in patients undergoing cardiovascular surgery. Patients at high risk of heart failure or with confirmed cardiac dysfunction will be randomly assigned to receive either vericiguat plus standard of care or standard of care alone. The primary objective is to determine whether perioperative administration of vericiguat can reduce (I) the Incidence of Early Postoperative Hemodynamic Deterioration or Clinically Significant Myocardial Injury; (II) Incidence of Major Sterile Inflammation-Related Organ Injuries (MSIRI), and the incidence of Major Adverse Cardiovascular Events (MACE) within 12 months after surgery.
详细描述
Perioperative pathophysiological changes in cardiovascular surgery, such as stress response, ischemia-reperfusion injury, and endothelial dysfunction, often lead to an increased risk of postoperative complications, especially postoperative heart failure and ventricular remodeling. This study hypothesizes that vericiguat, a novel oral soluble guanylate cyclase (sGC) stimulator, can improve endothelial function and reduce postoperative cardiovascular complications by repairing the impaired NO-sGC-cGMP signaling pathway. This is a multicenter, randomized, parallel-group, controlled trial. A total of 600 eligible patients will be randomized in a 1:1 ratio. The experimental group will receive oral vericiguat (starting at 2.5 mg once daily 3 days before surgery, and up-titrated to a target dose of 10 mg once daily postoperatively) in addition to standard perioperative care for 6 months. The control group will receive standard perioperative care alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (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
- •Aged 18 to 80 years, any sex;
- •Scheduled to undergo cardiovascular surgery at the study centers, including coronary artery bypass grafting (CABG), heart valve replacement/repair, and great vessel surgery;
- •Preoperative evaluation indicates a high risk of heart failure or confirmed cardiac dysfunction;
- •Systolic blood pressure (SBP) >= 100 mmHg;
- •Expected to complete the 6-month postoperative follow-up;
- •Signed written informed consent by the patient or their authorized representative.
排除标准
- •Current use of other sGC stimulators or phosphodiesterase type 5 (PDE-5) inhibitors (e.g., sildenafil, tadalafil);
- •Severe hypotension (symptomatic hypotension or resting SBP < 90 mmHg);
- •Severe hepatic or renal dysfunction (Hepatic: Child-Pugh class C, or ALT/AST > 3 times the upper limit of normal; Renal: eGFR < 15 mL/min/1.73m^2, or requiring chronic dialysis);
- •Malignant tumors, severe hematological diseases, or severe malnutrition (albumin < 25 g/L);
- •Known allergy to vericiguat or placebo components;
- •Pregnant or lactating women, or those planning to become pregnant during the study period;
- •Currently participating in other interventional clinical trials;
- •Moderate to severe cognitive impairment without a fixed guardian, unable to cooperate with treatment and follow-up;
- •Confirmed severe infection, sepsis, or septic shock preoperatively.
研究者
Hong Liu
Investigator of Department of Cardiac Surgery
Nanjing Medical University