A Phase 4 interventional study of treatment discontinuation and treatment continuation in Heart Failure and Cardiac Surgery, sponsored by University Hospital, Toulouse. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by University Hospital, Toulouse · Phase 4, Interventional, and Treatment
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.
Investigator team will compare patients who continue SGLT-2 inhibitors preoperatively with those who discontinue SGLT-2 inhibitors 3 days before surgery. Patients scheduled for elective cardiac surgery with cardiopulmonary bypass will be seen in an anesthesia consultation at least 4 days before surgery. During the consultation, the study will be proposed to the patient. After receiving written information and signing the informed consent form, baseline data, will be collected, and the patient will be randomized into one of the two study groups. The patient and the anesthesia and cardiac surgery teams will not be blinded. Indeed, Investigator team aim to conduct a pragmatic study that closely reflects clinical reality. Postoperatively, patients will be managed according to each service's usual practices. Investigator team's goal is to reflect real-world conditions. Following surgery, SGLT-2 inhibitors will be administrated once hemodynamics are stable. Five visits are scheduled in the protocol: 4 at 7 days before surgery, the day before surgery, at 7 days, upon hospital discharge, and 30 days after the intervention to assess the occurrence of the various outcome criteria.
Exclusion Criteria:
patients who continue SGLT-2 inhibitors preoperatively
Drug: treatment continuation · Diagnostic Test: ketone levels
patients who discontinue SGLT-2 inhibitors 3 days before surgery
Drug: treatment discontinuation · Diagnostic Test: ketone levels
stop the SGLT-2 inhibitors treatment (dapagliflozine or empagliflozine) 3 days before surgery
maintain SGLT-2i treatment (dapagliflozine or empagliflozine) until surgery morning included
Measurement of capillary ketone levels
postoperative cardiovascular outcomes
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
Time frame: day 30 after surgery
Perioperative myocardial ischemia
postoperative myocardial ischemia defined by 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
Time frame: day 2 after surgery
Postoperative low cardiac output syndrome
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
Time frame: day 7 after surgery
Rehospitalization
Rehospitalization within 30 days post-surgery for left heart failure
Time frame: day 30 after surgery
mortality
All-cause mortality
Time frame: day 7 after surgery
mortality
All-cause mortality
Time frame: day 30 after surgery
Euglycemic diabetic ketoacidosis
Euglycemic diabetic ketoacidosis
Time frame: day 7 after surgery
Acute kidney injury
Acute kidney injury within 7 postoperative days, it will be considered present in the case of KDIGO stage ≥ 2
Time frame: day 7 after surgery
Quality of life assessed with an EQ5D test performed at day 30
Quality of life assessed with an EQ5D test performed at day 30
Time frame: day 30 after surgery
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University Hospital, Toulouse