Discontinuation or Continuation of SGLT-2 Inhibitors Before Cardiac Surgery

NCT07766109 | Not Yet Recruiting Phase 4

• 2 other identifiers: RC31/25/04432025-524395-30-00
• Study Type: interventional
• Target: 434
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure; Cardiac Surgery

Keywords

perioperative care; SGLT-2 inhibitor

Outcome Measures

Primary Outcomes (1)

• 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

  day 30 after surgery

Secondary Outcomes (8)

• Perioperative myocardial ischemia

  day 2 after surgery

• Postoperative low cardiac output syndrome

  day 7 after surgery

• Rehospitalization

  day 30 after surgery

• mortality

  day 7 after surgery

• mortality

  day 30 after surgery

Study Arms (2)

Continuation of SGLT-2 Inhibitors Before Cardiac Surgery

EXPERIMENTAL

patients who continue SGLT-2 inhibitors preoperatively

Drug: treatment continuation; Diagnostic Test: ketone levels

Discontinuation of SGLT-2 Inhibitors Before Cardiac Surgery

OTHER

patients who discontinue SGLT-2 inhibitors 3 days before surgery

Drug: treatment discontinuation; Diagnostic Test: ketone levels

Interventions

treatment discontinuation DRUG

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

Discontinuation of SGLT-2 Inhibitors Before Cardiac Surgery

treatment continuation DRUG

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

Continuation of SGLT-2 Inhibitors Before Cardiac Surgery

ketone levels DIAGNOSTIC_TEST

Measurement of capillary ketone levels

Continuation of SGLT-2 Inhibitors Before Cardiac Surgery; Discontinuation of SGLT-2 Inhibitors Before Cardiac Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital of TOULOUSE

Toulouse, France

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• François LABASTE, MD_PH

  University Hospital of Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

François LABASTE, MD-PH

CONTACT

05 61 32 28 22; labaste.f@chu-toulouse.fr

Magali CENTELLES

CONTACT

centelles.m@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: August 14, 2026

Record last verified: 2026-08

Locations

FR (1)