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Perioperative Vericiguat in Patients Undergoing Cardiovascular Surgery

11 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

600

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: 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.
Comparateur actif: 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.
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incidence of Early Postoperative Hemodynamic Deterioration or Clinically Significant Myocardial Injury
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Nanjing Medical University

Collaborateurs

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

Les enquêteurs

  • Chercheur principal: Si-chong Qian, MD, Beijing Anzhen Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

31 mai 2026

Achèvement primaire (Estimé)

31 décembre 2028

Achèvement de l'étude (Estimé)

31 décembre 2030

Dates d'inscription aux études

Première soumission

11 mai 2026

Première soumission répondant aux critères de contrôle qualité

11 mai 2026

Première publication (Réel)

18 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • PANDA XIII

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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