Perioperative Vericiguat in Patients Undergoing Cardiovascular Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNanjing Medical University

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

600 Participants
are divided into 2 treatment groups

Locations

1
The First Affiliated Hospital of Nanjing Medical University210029, NanjingJiangsu, China

Sponsors 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