Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07766109

Discontinuation or Continuation of SGLT-2 Inhibitors Before Cardiac Surgery

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital of TOULOUSE

Toulouse, France

Location contact

François LABASTE, MD-PH

CONTACT

[email protected]

François LABASTE, MD-PH

PRINCIPAL_INVESTIGATOR

Magali CENTELLES

CONTACT

[email protected]

About this study

Investigator team will compare patients who continue SGLT-2 inhibitors preoperatively with those who discontinue SGLT-2 inhibitors 3 days before surgery. Patients scheduled for elective cardiac surgery with cardiopulmonary bypass will be seen in an anesthesia consultation at least 4 days before surgery. During the consultation, the study will be proposed to the patient. After receiving written information and signing the informed consent form, baseline data, will be collected, and the patient will be randomized into one of the two study groups. The patient and the anesthesia and cardiac surgery teams will not be blinded. Indeed, Investigator team aim to conduct a pragmatic study that closely reflects clinical reality. Postoperatively, patients will be managed according to each service's usual practices. Investigator team's goal is to reflect real-world conditions. Following surgery, SGLT-2 inhibitors will be administrated once hemodynamics are stable. Five visits are scheduled in the protocol: 4 at 7 days before surgery, the day before surgery, at 7 days, upon hospital discharge, and 30 days after the intervention to assess the occurrence of the various outcome criteria.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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
  • 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.

Treatment and study plan

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

Primary outcomes

  1. postoperative cardiovascular outcomes

    Time frame: day 30 after surgery

    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

Secondary outcomes

  1. Perioperative myocardial ischemia

    Time frame: day 2 after surgery

    postoperative myocardial ischemia defined by 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

  2. Postoperative low cardiac output syndrome

    Time frame: day 7 after surgery

    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

  3. Rehospitalization

    Time frame: day 30 after surgery

    Rehospitalization within 30 days post-surgery for left heart failure

  4. mortality

    Time frame: day 7 after surgery

    All-cause mortality

  5. mortality

    Time frame: day 30 after surgery

    All-cause mortality

  6. Euglycemic diabetic ketoacidosis

    Time frame: day 7 after surgery

    Euglycemic diabetic ketoacidosis

  7. Acute kidney injury

    Time frame: day 7 after surgery

    Acute kidney injury within 7 postoperative days, it will be considered present in the case of KDIGO stage ≥ 2

  8. Quality of life assessed with an EQ5D test performed at day 30

    Time frame: day 30 after surgery

    Quality of life assessed with an EQ5D test performed at day 30

Study contacts

Contact information is provided by the study sponsor or research team.

François LABASTE, MD-PH

CONTACT

[email protected]

05 61 32 28 22 ext. +33

Magali CENTELLES

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: DISCO

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.