Not Yet RecruitingNot Applicable

Perioperative Vericiguat in Patients Undergoing Cardiovascular Surgery

China600 participantsStarted 2026-05-31

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Early Postoperative Hemodynamic Deterioration or Clinically Significant Myocardial Injury

Timeframe: Up to 7 days postoperatively (or until ICU discharge, whichever comes first).

Incidence of Major Adverse Cardiovascular Events (MACE)

Timeframe: Up to 6 months postoperatively

Incidence of Major Sterile Inflammation-Related Organ Injuries (MSIRI)

Timeframe: Up to 7 days postoperatively.

Maximum Sequential Organ Failure Assessment (SOFA) Score

Timeframe: Up to 7 days postoperatively.

Trial details

NCT IDNCT07594509

SponsorNanjing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Hong Liu

18801281613 DR.HONGLIU@FOXMAIL.COM

View on ClinicalTrials.gov More Cardio Vascular Disease trials

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence of Early Postoperative Hemodynamic Deterioration or Clinically Significant Myocardial Injury

Timeframe: Up to 7 days postoperatively (or until ICU discharge, whichever comes first).

Incidence of Major Adverse Cardiovascular Events (MACE)

Timeframe: Up to 6 months postoperatively

Incidence of Major Sterile Inflammation-Related Organ Injuries (MSIRI)

Timeframe: Up to 7 days postoperatively.

Maximum Sequential Organ Failure Assessment (SOFA) Score

Timeframe: Up to 7 days postoperatively.