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