About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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/1.73m², or requiring chronic dialysis);
Malignant tumors, severe hematological diseases, or severe malnutrition (albumin < 25 g/L);
Trial design
Treatments tested in this trial
- Vericiguat
- Standard of Care Group
Treatment groups
Locations
1Sponsors and collaborators
Nanjing Medical University
Lead sponsor
Beijing Anzhen Hospital
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
Changzhou First People's Hospital
Collaborator
The First Affiliated Hospital of Guangzhou Medical University
Collaborator
The First Affiliated Hospital of Bengbu Medical University
Collaborator
West China Hospital
Collaborator
Shanghai East Hospital, China
Collaborator