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NCT07766109Not yet recruitingPhase 4

Discontinuation or Continuation of SGLT-2 Inhibitors Before Cardiac Surgery

Discontinuation or Continuation of SGLT-2 Inhibitors Before Cardiac Surgery: Impact on Postoperative Cardiovascular Outcomes - DISCO Study

Source: ClinicalTrials.gov · Last updated 5 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
434 (estimated)
First submitted
10 Aug 2026
Start date
Dec 2026
Primary completion date
Mar 2029
Lead sponsor
University Hospital, Toulouse
NCT number
NCT07766109
EU CT number
2025-524395-30-00

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 434
  • From Dec 2026 to the primary completion date, Mar 2029
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment with SGLT-2 inhibitors initiated less than 4 weeks ago and other than empagliflozine or dapagliflozine
  • surgery scheduled within less than 3 days
  • surgery for active endocarditis within the last 3 months

Other illness

  • 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
  • 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

Lab values

  • 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
  • heart failure patients with a preserved ejection fraction, equal to or greater than 50

Other

  • patients on preoperative mechanical circulatory support
  • 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.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre hospitalier Universitaire de Bordeaux
Coordinator of this site? Confirm its status
BordeauxFranceNot yet recruiting
Centre Hospitalier Universitaire De Montpellier
Coordinator of this site? Confirm its status
Montpellier Cedex 5FranceNot yet recruiting
Centre Hospitalier Universitaire de Toulouse
Coordinator of this site? Confirm its status
ToulouseFranceNot yet recruiting
Clinique Pasteur
Coordinator of this site? Confirm its status
Toulouse Cedex 3FranceNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.