Could continuing a common heart drug before surgery save lives?
NCT ID NCT07766109
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This trial asks whether people with heart failure who take SGLT-2 inhibitors (like dapagliflozin or empagliflozin) should continue the medication right up to cardiac surgery, rather than stopping it three days before as currently recommended. The study will compare outcomes like heart damage, low cardiac output, rehospitalization, and death within 30 days after surgery. About 434 adults scheduled for heart surgery with a heart pump will be randomly assigned to either continue or stop their medication. The goal is to see if keeping the drug on board improves recovery and reduces complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SGLT-2 inhibitors (dapagliflozin or empagliflozin) continued until surgery morning versus stopped 3 days before
- What this could lead to
- If continuing SGLT-2 inhibitors before cardiac surgery proves beneficial, it could reduce heart complications and hospital readmissions after surgery.
- What could go wrong
- This is a phase 4 trial with 434 patients, so results may not apply to all. There is a known risk of ketoacidosis if the drug is continued, and the trial may not show a clear benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 434 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Hospital of TOULOUSE
Toulouse, France
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Other studies related to the condition(s) this trial covers.
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- Can better training get doctors to talk about what matters most to dying veterans?
- Can AI read heart ultrasounds as well as trained sonographers?