Perioperative Vericiguat in Patients Undergoing Cardiovascular Surgery

May 11, 2026 updated by: Hong Liu, Nanjing Medical University

A Multicenter, Randomized, Controlled Trial to Evaluate the Efficacy and Safety of Perioperative Vericiguat in Patients Undergoing Cardiovascular Surgery

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Perioperative pathophysiological changes in cardiovascular surgery, such as stress response, ischemia-reperfusion injury, and endothelial dysfunction, often lead to an increased risk of postoperative complications, especially postoperative heart failure and ventricular remodeling. This study hypothesizes that vericiguat, a novel oral soluble guanylate cyclase (sGC) stimulator, can improve endothelial function and reduce postoperative cardiovascular complications by repairing the impaired NO-sGC-cGMP signaling pathway. This is a multicenter, randomized, parallel-group, controlled trial. A total of 600 eligible patients will be randomized in a 1:1 ratio. The experimental group will receive oral vericiguat (starting at 2.5 mg once daily 3 days before surgery, and up-titrated to a target dose of 10 mg once daily postoperatively) in addition to standard perioperative care for 6 months. The control group will receive standard perioperative care alone.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Vericiguat Group
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
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.
Active Comparator: Standard of Care Group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Early Postoperative Hemodynamic Deterioration or Clinically Significant Myocardial Injury
Time Frame: Up to 7 days postoperatively (or until ICU discharge, whichever comes first).

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)
Time Frame: Up to 6 months postoperatively
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)
Time Frame: Up to 7 days postoperatively.
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
Time Frame: Up to 7 days postoperatively.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanjing Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
West China Hospital
The Affiliated Hospital of Qingdao University
Beijing Anzhen Hospital
The First Affiliated Hospital of Guangzhou Medical University
Shanghai East Hospital, China
Changzhou First People's Hospital
The First Affiliated Hospital of Bengbu Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Si-chong Qian, MD, Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PANDA XIII

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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