Discontinuation or Continuation of SGLT-2 Inhibitors Before Cardiac Surgery

NCT07766109 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Toulouse

Phase

Phase 4

Started

2026-10

Last updated

2026-08-14

Condition(s) studied

Heart FailureCardiac Surgery

Investigational drug(s) / intervention(s)

treatment discontinuationtreatment continuationketone levels

treatment discontinuation: stop the SGLT-2 inhibitors treatment (dapagliflozine or empagliflozine) 3 days before surgery

treatment continuation: maintain SGLT-2i treatment (dapagliflozine or empagliflozine) until surgery morning included

ketone levels: Measurement of capillary ketone levels

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

postoperative cardiovascular outcomes — day 30 after surgery
composite criterion describing postoperative cardiovascular outcomes and will include: the occurrence of postoperative myocardial ischemia by day 2 (elevation of troponin I more than 218 times the laboratory threshold value for patients undergoing coronary artery bypass grafting or aortic valve replacement/repair surgery; the threshold will be 499 times the laboratory threshold value for other types of surgery) ; and/or the occurrence of postoperative low cardiac output syndrome in the ICU (defined by the administration of inotropes for more than 48 hours and/or the use of mechanical circulatory support); and/or rehospitalization by day 30 for heart failure (defined by the need for initiation or increase of diuretics and/or administration of inotropes and/or the use of invasive or non-invasive mechanical ventilation for acute pulmonary edema); and/or postoperative mortality by day 30

Trial sites (1)

Facility	City	Region	Status
University Hospital of TOULOUSE	Toulouse	France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07766109 on ClinicalTrials.gov ↗ ← All trials in France