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Not Yet Recruiting NCT07766109

Discontinuation or Continuation of SGLT-2 Inhibitors Before Cardiac Surgery

Conditions: Heart Failure, Cardiac Surgery

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 434
Sponsor: University Hospital, Toulouse

Location: University Hospital of TOULOUSE Toulouse

Summary

SGLT-2 inhibitors are recommended treatments for managing heart failure patients. In cases of surgery, it is recommended to stop the treatment 3 days before surgery due to the risk of postoperative euglycemic diabetic ketoacidosis. However, several data suggest that it may be beneficial to maintain SGLT-2i treatment given the possibility of improving postoperative cardiovascular outcomes. Investigator team wish to conduct a randomized controlled trial to test the hypothesis that preoperative maintenance of SGLT-2i is superior to discontinuing them 3 days before surgery in improving postoperative cardiovascular outcomes.

Eligibility Criteria

Inclusion Criteria: * Adult patients scheduled to undergo cardiac surgery with cardiopulmonary bypass * patients treated with SGLT-2 inhibitors, including combined treatment with metformin, for at least 4 weeks * heart failure patients with a left ventricular ejection fraction strictly below 50% * patients enrolled in a social security scheme or equivalent * patients who have signed the informed consent form Exclusion Criteria: * Treatment with SGLT-2 inhibitors initiated less than 4 weeks ago and other than empagliflozine or dapagliflozine * patients with a contraindication to SGLT-2 inhibitors: hypersensitivity, type 1 diabetes mellitus, and renal impairment with an estimated glomerular filtration rate below 25 mL/min/1.73 m² * acute conditions likely to call into question the continuation of SGLT2 inhibitor therapy (alone or in combination) at the time of inclusion, including in particular: shock state or acute tissue hypoxia (episode of hyperlactatemia \> 3 mmol/L within 7 days prior to inclusion); acute kidney injury within the previous 7 days (KDIGO stage ≥2); severe hepatocellular failure (factor V level \< 50%); acute alcohol intoxication within the previous 7 days or active alcohol use disorder without withdrawal * surgery scheduled within less than 3 days * surgery for active endocarditis within the last 3 months * patients on preoperative mechanical circulatory support * heart transplant surgery or implantation of an LVAD (left ventricular assist device) * chronic kidney disease patients with a glomerular filtration rate below 25 mL/min/1.73m² * heart failure patients with a preserved ejection fraction, equal to or greater than 50 * pregnant or breastfeeding women * minors or adults under legal protection (guardianship or conservatorship) * patients participating in another interventional study patients who do not understand or speak French.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07766109). StuddyBuddy aggregates publicly available trial information.