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Could continuing a common heart drug before surgery save lives?

NCT ID NCT07766109

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 434 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • University Hospital of TOULOUSE

    Toulouse, France

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