Perioperative Vericiguat in Patients Undergoing Cardiovascular Surgery

Summary

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.

Conditions

• Cardio Vascular Disease
• Cardiopulmonary Bypass

Interventions

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.

DRUG

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.

Sponsors & Collaborators

• Beijing Anzhen Hospital

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Changzhou First People's Hospital

  collaborator UNKNOWN

• The First Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• The First Affiliated Hospital of Bengbu Medical University

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Shanghai East Hospital, China

  collaborator UNKNOWN

• Nanjing Medical University

  lead OTHER

Principal Investigators

• Si-chong Qian, MD · Beijing Anzhen Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-31

Primary Completion

2028-12-31

Completion

2030-12-31

Countries

• China

Study Locations