Cardio Vascular DiseaseNCT07594509
Perioperative Vericiguat in Patients Undergoing Cardiovascular Surgery
A study testing Vericiguat in people with Cardio Vascular Disease and Cardiopulmonary Bypass, run by Nanjing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardio Vascular Disease, Cardiopulmonary Bypass
- What is being tested?
- Vericiguat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardio Vascular Disease, Cardiopulmonary Bypass
- Being tested
- Vericiguat, Standard of Care Group
- Keywords
- cardiovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VericiguatDrug
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 GroupDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Standard of Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
- 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.
- Cardiovascular Death within 7 days.
Measured: 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.
Measured: 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):
Measured: 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.
Measured: Up to 7 days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start31 May 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardio Vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Anzhen Hospital, The Affiliated Hospital of Qingdao University, Changzhou First People's Hospital, The First Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Bengbu Medical University, West China Hospital, Shanghai East Hospital
- Responsible party
- Principal investigator, Hong Liu, Nanjing Medical University
- Investigators
- Si-chong Qian, MD, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594509
- Sponsor's protocol ID
- PANDA XIII
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Trial to Evaluate the Efficacy and Safety of Perioperative Vericiguat in Patients Undergoing Cardiovascular Surgery
- ClinicalTrials.gov ID
- NCT07594509
- Acronym / sponsor ID
- PANDA XIII
- Conditions
- Cardio Vascular Disease, Cardiopulmonary Bypass
- Keywords
- cardiovascular
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing Anzhen Hospital, The Affiliated Hospital of Qingdao University, Changzhou First People's Hospital, The First Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Bengbu Medical University, West China Hospital, Shanghai East Hospital
- Study start
- 31 May 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vericiguat Group | Experimental | Drug: VericiguatDrug: 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. |
| Standard of Care Group | Active comparator | Drug: Standard of Care GroupStandard 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VericiguatPatients 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 Group |
| Standard of Care GroupPatients 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 |
Primary outcome
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.
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.
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):
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Si-chong Qian, MD principal investigator
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vericiguat in people with Cardio Vascular Disease and Cardiopulmonary Bypass, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong Liu (18801281613, DR.HONGLIU@FOXMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.