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Discontinuation or Continuation of SGLT-2 Inhibitors Before Cardiac Surgery: Impact on Postoperative Cardiovascular Outcomes
EU CTIS ID: 2025-524395-30-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 who have signed the informed consent form
- patients enrolled in a social security scheme or equivalent
You likely can't join if
- Treatment with SGLT-2i introduced less than 4 weeks ago or with SGLT-2i other than empagliflozin or dapagliflozin
- Patients on preoperative mechanical circulatory support
- Heart transplant surgery or LVAD (Left Ventricular Assist Device) implantation
- Patients with chronic renal failure with a 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.
- Patients with heart failure and preserved ventricular ejection fraction greater than or equal to 50%
See the full eligibility 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 who have signed the informed consent form
- patients enrolled in a social security scheme or equivalent
- Treatment with SGLT-2i introduced less than 4 weeks ago or with SGLT-2i other than empagliflozin or dapagliflozin
- Patients on preoperative mechanical circulatory support
- Heart transplant surgery or LVAD (Left Ventricular Assist Device) implantation
- Patients with chronic renal failure with a 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.
- Patients with heart failure and preserved ventricular ejection fraction greater than or equal to 50%
- Pregnant or breastfeeding women
- 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
- Minors or adult patients under protective measures (guardianship, trusteeship, or judicial protection)
- Patients who do not understand or speak French.
- Patients participating in another interventional study
- Surgery within less than 3 days
- Surgery for active endocarditis lasting less than 3 months
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.