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
- Diseases
- Heart failure
- 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
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Not yet recruiting |
| Clinique Pasteur Coordinator of this site? Confirm its status | Toulouse Cedex 3 | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.