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| Name | Class |
|---|---|
| Beijing Anzhen Hospital | OTHER |
| The Affiliated Hospital of Qingdao University | OTHER |
| Changzhou First People's Hospital | UNKNOWN |
| The First Affiliated Hospital of Guangzhou Medical University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vericiguat Group | Experimental | Drug: Vericiguat Patients will receive oral vericiguat in addition to standardized perioperative care. Vericiguat will be initiated 3 days before surgery at a dose of 2.5 mg once daily. Postoperatively, upon resumption of enteral nutrition, vericiguat will be continued and gradually up-titrated every 2 weeks based on blood pressure tolerability to 5 mg, and then to a target dose of 10 mg once daily, taken with food, for a total duration of 1 months. |
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| Standard of Care Group | Active Comparator | Standard of Care Group Patients will receive standardized perioperative cardiovascular surgery care alone, without vericiguat or placebo. Standard care includes preoperative preparation, postoperative monitoring, anti-infection, antiplatelet/anticoagulation, diuretics, beta-blockers, SGLT2 inhibitors, and other symptomatic treatments for heart failure according to current guidelines. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vericiguat | Drug | Patients will receive oral vericiguat in addition to standardized perioperative care. Vericiguat will be initiated 3 days before surgery at a dose of 2.5 mg once daily. Postoperatively, upon resumption of enteral nutrition, vericiguat will be continued and gradually up-titrated every 2 weeks based on blood pressure tolerability to 5 mg, and then to a target dose of 10 mg once daily, taken with food, for a total duration of 1 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Early Postoperative Hemodynamic Deterioration or Clinically Significant Myocardial Injury | A composite endpoint defined as the occurrence of any of the following within 7 days after surgery:
| Up to 7 days postoperatively (or until ICU discharge, whichever comes first). |
| Incidence of Major Adverse Cardiovascular Events (MACE) | MACE is defined as a composite endpoint including: cardiovascular death, non-fatal myocardial infarction, ischemic stroke, severe arrhythmia, and readmission due to worsening heart failure. | Up to 6 months postoperatively |
| Incidence of Major Sterile Inflammation-Related Organ Injuries (MSIRI) | A composite clinical endpoint defined as the occurrence of any of the following severe sterile inflammatory complications within 7 days after surgery, in the absence of proven bacterial infection (defined as negative blood/sputum cultures AND Procalcitonin [PCT] < 0.5$ ng/mL): | Up to 7 days postoperatively. |
| Maximum Sequential Organ Failure Assessment (SOFA) Score | The SOFA score evaluates 6 organ systems (respiratory, coagulation, liver, cardiovascular, central nervous system, and renal), with each system scored from 0 (normal) to 4 (highest degree of dysfunction). The total score ranges from 0 to 24, where higher scores indicate more severe multi-organ dysfunction. The maximum total SOFA score recorded during the first 7 postoperative days will be compared between groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Liu | Contact | 18801281613 | DR.HONGLIU@FOXMAIL.COM | |
| Zhi Li, MD | Contact | 02568303101 | zhili_cths@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Si-chong Qian, MD | Beijing Anzhen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210029 | China |
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| ID | Term |
|---|---|
| C000603960 | vericiguat |
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| OTHER |
| The First Affiliated Hospital of Bengbu Medical University | OTHER |
| West China Hospital | OTHER |
| Shanghai East Hospital, China | UNKNOWN |
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| Standard of Care Group | Drug | Patients will receive standardized perioperative cardiovascular surgery care alone, without vericiguat or placebo. Standard care includes preoperative preparation, postoperative monitoring, anti-infection, antiplatelet/anticoagulation, diuretics, beta-blockers, SGLT2 inhibitors, and other symptomatic treatments for heart failure according to current guidelines. |
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| Up to 7 days postoperatively. |