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Perioperative Vericiguat in Patients Undergoing Cardiovascular Surgery

ConditionsCardio Vascular DiseaseCardiopulmonary Bypass
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Vericiguat GroupExperimental treatment 1 intervention
Group B: Standard of Care GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 7 days postoperatively (or until ICU discharge, whichever comes first).
2

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.

Time frame
Up to 6 months postoperatively
3

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):

Time frame
Up to 7 days postoperatively.
4

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.

Time frame
Up to 7 days postoperatively.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Source ClinicalTrials.gov

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