Perioperative Vericiguat in Patients Undergoing Cardiovascular Surgery

NCT07594509 | Not Yet Recruiting DMC

• 1 other identifier: PANDA XIII
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cardiovascular

Outcome Measures

Primary Outcomes (4)

• 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: 1. Severe Hemodynamic Deterioration (Low Cardiac Output Syndrome, LCOS): Defined by the need for new mechanical circulatory support (e.g., IABP, ECMO) postoperatively, OR a Vasoactive-Inotropic Score (VIS) $\\ge$ 15 sustained for at least 12 consecutive hours. 2. Clinically Significant Perioperative Myocardial Infarction/Injury: Based on the Fourth Universal Definition of Myocardial Infarction (Type 5) or ARC-2 criteria, defined as severe elevation of cardiac biomarkers (e.g., cTn \> 10x 99th percentile URL) accompanied by new ischemic ECG changes or new regional wall motion abnormalities on echocardiography. 3. Cardiovascular Death within 7 days.

  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.

  Up to 7 days postoperatively.

Study Arms (2)

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.

Drug: Vericiguat

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.

Drug: Standard of Care Group

Interventions

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.

Vericiguat Group

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.

Standard of Care Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Anzhen Hospital: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• The First Affiliated Hospital of Bengbu Medical University: collaborator
• Nanjing Medical University: lead
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• West China Hospital: collaborator
• Shanghai East Hospital, China: collaborator
• Changzhou First People's Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Interventions

vericiguat

Study Officials

• Si-chong Qian, MD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Liu

CONTACT

18801281613; DR.HONGLIU@FOXMAIL.COM

Zhi Li, MD

CONTACT

02568303101; zhili_cths@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator of Department of Cardiac Surgery

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

CN (1)