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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Toulouse

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2026-05-29

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Prophylaxis, Safety

The primary objective will be to demonstrate the superiority of continuing SGLT-2 inhibitors preoperatively until the morning of surgery versus discontinuing SGLT-2 inhibitors 3 days prior to surgery, on the 30-day cardiovascular outcome of patients with heart failure and impaired ejection fraction who have been treated for at least 4 weeks with SGLT-2 inhibitors and who are undergoing scheduled cardiac surgery with cardiopulmonary bypass.

Secondary objectives 10

1. Evaluate the impact of continuing SGLT-2 inhibitors preoperatively versus discontinuing them 3 days before surgery on the occurrence of perioperative myocardial injury at 2 days
2. Evaluate the impact of continuing SGLT-2i inhibitors preoperatively versus discontinuing them 3 days before surgery on the occurrence of low cardiac output syndrome at 7 days
3. Evaluate the impact of continuing SGLT-2i inhibitors preoperatively versus discontinuing them 3 days before surgery on the occurrence of rehospitalization for cardiac decompensation at D30
4. evaluate the impact of continuing SGLT-2i inhibitors preoperatively versus discontinuing them 3 days before surgery on the occurrence of all-cause mortality a) at 30 days and b) at 7 days postoperatively
5. Assess the impact of continuing versus discontinuing SGLT-2 inhibitors 3 days prior to surgery on the occurrence of euglycemic ketoacidosis within 7 days postoperatively
6. Assess the impact of continuing SGLT-2 inhibitors preoperatively versus discontinuing them 3 days before surgery on the occurrence of acute renal failure in intensive care within 7 days postoperatively
7. Assess the impact of continuing SGLT-2 inhibitors preoperatively versus discontinuing them 3 days before surgery on the time to resume SGLT-2 inhibitors postoperatively
8. Assess the impact of continuing SGLT-2 inhibitors preoperatively versus discontinuing them 3 days before surgery on quality of life 30 days postoperatively
9. Evaluate the impact of continuing SGLT-2 inhibitors preoperatively versus discontinuing them 3 days before surgery on the length of stay in intensive care
10. Evaluate the impact of continuing SGLT-2 inhibitors preoperatively versus discontinuing them 3 days before surgery on the length of hospital stay.

Conditions and MedDRA coding

heart failure

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Adult patients scheduled to undergo cardiac surgery with cardiopulmonary bypass
2. patients treated with SGLT-2 inhibitors, including combined treatment with metformin, for at least 4 weeks
3. heart failure patients with a left ventricular ejection fraction strictly below 50%
4. patients who have signed the informed consent form
5. patients enrolled in a social security scheme or equivalent

Exclusion criteria 13

1. Treatment with SGLT-2i introduced less than 4 weeks ago or with SGLT-2i other than empagliflozin or dapagliflozin
2. Patients with heart failure and preserved ventricular ejection fraction greater than or equal to 50%
3. Pregnant or breastfeeding women
4. Patients with a contraindication to the use of SGLT2 inhibitors: type 1 diabetes, known hypersensitivity, chronic kidney disease with an eGFR of less than 25 ml/min/1.73 m²
5. Minors or adult patients under protective measures (guardianship, trusteeship, or judicial protection)
6. Patients who do not understand or speak French.
7. Patients participating in another interventional study
8. Surgery within less than 3 days
9. Surgery for active endocarditis lasting less than 3 months
10. Patients on preoperative mechanical circulatory support
11. Heart transplant surgery or LVAD (Left Ventricular Assist Device) implantation
12. Patients with chronic renal failure with a glomerular filtration rate below 25 mL/min/1.73 m2
13. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. composite endpoint, describing postoperative cardiovascular outcomes, namely: – Perioperative myocardial injury within the first 48 hours postoperatively, defined by an increase in high-sensitivity troponin I (HS). – Low cardiac output syndrome within 7 days postoperatively – Rehospitalisation at 30 days postoperatively for left heart failure – All-cause mortality at 30 days postoperatively.

Secondary endpoints 10

1. Postoperative myocardial injury within the first 48 hours after surgery, defined by an increase in high-sensitivity troponin I (HS). The thresholds will be 218 times the laboratory threshold value for patients undergoing coronary artery bypass grafting or aortic valve replacement or repair surgery. For patients undergoing other types of cardiac surgery, the threshold will be 499 times the laboratory threshold value.
2. Postoperative low cardiac output syndrome occurring within 7 days postoperatively, defined by infusion of positive inotropes for more than 48 hours and/or the need for temporary mechanical circulatory support postoperatively (ECLS, CPIA, Impella®).
3. Rehospitalisation within 30 days of surgery for left heart failure defined by the need for introduction or increase in diuretics and/or administration of positive inotropes and/or use of invasive or non-invasive ventilation for acute pulmonary oedema. Only stays in cardiology departments, including intensive care, cardiac surgery or resuscitation, will be considered.
4. All-cause mortality a) at 30 days b) at 7 days
5. Euglycaemic ketoacidosis defined by a pH < 7.35 and the presence of capillary ketonemia > 0.6 mmol/l and capillary blood glucose < 2.5 g/l within 7 days post-operatively.
6. Acute renal failure defined as a KDIGO (Kidney Disease Improving Global Outcome) score ≥ 2, occurring in intensive care within 7 days.
7. The delay in days before postoperative resumption of SGLT-2 inhibitors
8. Quality of life will be assessed using an EQ5D test carried out the day before surgery and on day 30.
9. Length of stay in intensive care in days
10. Length of hospital stay in days

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Toulouse

Sponsor organisation

Centre Hospitalier Universitaire De Toulouse

Address

2 Rue Viguerie

City

Toulouse

Postcode

31300

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Toulouse

Contact name

Principal investigator

Public contact point

Organisation

Centre Hospitalier Universitaire De Toulouse

Contact name

Principal investigator

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications