Discontinuation or Continuation of SGLT-2 Inhibitors Before Cardiac Surgery
NCT07766109 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 434
Last updated 2026-08-14
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
Interventions
- DRUG
-
treatment discontinuation
stop the SGLT-2 inhibitors treatment (dapagliflozine or empagliflozine) 3 days before surgery
- DRUG
-
treatment continuation
maintain SGLT-2i treatment (dapagliflozine or empagliflozine) until surgery morning included
- DIAGNOSTIC_TEST
-
ketone levels
Measurement of capillary ketone levels
Sponsors & Collaborators
-
University Hospital, Toulouse
lead OTHER
Principal Investigators
-
François LABASTE, MD_PH · University Hospital of Toulouse
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-10-31
- Primary Completion
- 2029-01-31
- Completion
- 2029-01-31
Countries
- France
Study Locations
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