Health TrialsbyHealthPanel

Discontinuation or Continuation of SGLT-2 Inhibitors Before Cardiac Surgery

ConditionsHeart FailureCardiac Surgery
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

434 Participants
are divided into 2 treatment groups
Group A: Continuation of SGLT-2 Inhibitors Before Cardiac SurgeryExperimental treatment 2 interventions
Group B: Discontinuation of SGLT-2 Inhibitors Before Cardiac SurgeryOther 2 interventions

Trial outcomes

Primary outcomes

1

postoperative cardiovascular outcomes

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

Time frame
day 30 after surgery

Secondary outcomes

1

Perioperative myocardial ischemia

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

Time frame
day 2 after surgery
2

Postoperative low cardiac output syndrome

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

Time frame
day 7 after surgery
3

Rehospitalization

Rehospitalization within 30 days post-surgery for left heart failure

Time frame
day 30 after surgery
4

mortality

All-cause mortality

Time frame
day 7 after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Toulouse

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: