Discontinuation or Continuation of SGLT-2 Inhibitors Before Cardiac Surgery

Sponsor
University Hospital, Toulouse
Study ID
NCT07766109
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • treatment discontinuation — DRUG
    stop the SGLT-2 inhibitors treatment (dapagliflozine or empagliflozine) 3 days before surgery
  • treatment continuation — DRUG
    maintain SGLT-2i treatment (dapagliflozine or empagliflozine) until surgery morning included
  • ketone levels — DIAGNOSTIC_TEST
    Measurement of capillary ketone levels

Study Details

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.

Key Dates

First listed
Aug 14, 2026
Start date
Oct 31, 2026
Status verified
Aug 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
434 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Continuation of SGLT-2 Inhibitors Before Cardiac Surgery
    patients who continue SGLT-2 inhibitors preoperatively
  • Other: Discontinuation of SGLT-2 Inhibitors Before Cardiac Surgery
    patients who discontinue SGLT-2 inhibitors 3 days before surgery

Primary Outcome Measure

postoperative cardiovascular outcomes [ Time Frame: day 30 after surgery ]

Central Contacts

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