Perioperative Vericiguat in Patients Undergoing Cardiovascular Surgery
Starting soon · Not applicable · Has a placebo group
Conditions studied: Cardio Vascular Disease, Cardiopulmonary Bypass
In brief
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.
Key facts
- Study ID
- NCT07594509
- Run by
- Nanjing Medical University
- People needed
- 600
- Starts
- 2026-05-31
- Expected to finish
- 2030-12-31
- Last updated by the study team
- 2026-05-18
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China
Full record on ClinicalTrials.gov
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