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Heart FailurePhase 4DISCONCT07766109

Discontinuation or Continuation of SGLT-2 Inhibitors Before Cardiac Surgery

A Phase 4 study testing treatment discontinuation, treatment continuation and ketone levels in people with Heart Failure and Cardiac Surgery, run by University Hospital, Toulouse at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Cardiac Surgery
What is being tested?
treatment discontinuation, treatment continuation and ketone levels
Could I receive a placebo?
No, everyone receives an active treatment
How many people
434 participants
Where
1 siteFrance
Study dates
Dec 2026to Mar 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

François LABASTE, MD-PH contact

05 61 32 28 22 ext. +33

labaste.f@chu-toulouse.fr

Magali CENTELLES contact

centelles.m@chu-toulouse.fr

France1 site

  • University Hospital of TOULOUSE

    Toulouse

    François LABASTE, MD-PH, labaste.f@chu-toulouse.fr

    Magali CENTELLES, centelles.m@chu-toulouse.fr

Other trials in France

About this study

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

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.

Read the detailed description

Investigator team will compare patients who continue SGLT-2 inhibitors preoperatively with those who discontinue SGLT-2 inhibitors 3 days before surgery. Patients scheduled for elective cardiac surgery with cardiopulmonary bypass will be seen in an anesthesia consultation at least 4 days before surgery. During the consultation, the study will be proposed to the patient. After receiving written information and signing the informed consent form, baseline data, will be collected, and the patient will be randomized into one of the two study groups. The patient and the anesthesia and cardiac surgery teams will not be blinded. Indeed, Investigator team aim to conduct a pragmatic study that closely reflects clinical reality. Postoperatively, patients will be managed according to each service's usual practices. Investigator team's goal is to reflect real-world conditions. Following surgery, SGLT-2 inhibitors will be administrated once hemodynamics are stable. Five visits are scheduled in the protocol: 4 at 7 days before surgery, the day before surgery, at 7 days, upon hospital discharge, and 30 days after the intervention to assess the occurrence of the various outcome criteria.

Being tested
treatment discontinuation, treatment continuation, ketone levels
Keywords
perioperative care, SGLT-2 inhibitor
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • treatment discontinuationDrug

    stop the SGLT-2 inhibitors treatment (dapagliflozine or empagliflozine) 3 days before surgery

  • treatment continuationDrug

    maintain SGLT-2i treatment (dapagliflozine or empagliflozine) until surgery morning included

  • ketone levelsDiagnostic test

    Measurement of capillary ketone levels

Study groups in NCT07766109
Study groupRoleWhat they receive
Continuation of SGLT-2 Inhibitors Before Cardiac SurgeryExperimentalpatients who continue SGLT-2 inhibitors preoperatively
Receives: Drug: treatment continuation; Diagnostic Test: ketone levels
Discontinuation of SGLT-2 Inhibitors Before Cardiac SurgeryOtherpatients who discontinue SGLT-2 inhibitors 3 days before surgery
Receives: Drug: treatment discontinuation; Diagnostic Test: ketone levels

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: day 30 after surgery

Secondary outcomes (8)

  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

    Measured: 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

    Measured: day 7 after surgery

  3. Rehospitalization

    Rehospitalization within 30 days post-surgery for left heart failure

    Measured: day 30 after surgery

  4. mortality

    All-cause mortality

    Measured: day 7 after surgery

  5. mortality

    All-cause mortality

    Measured: day 30 after surgery

  6. Euglycemic diabetic ketoacidosis

    Euglycemic diabetic ketoacidosis

    Measured: day 7 after surgery

  7. Acute kidney injury

    Acute kidney injury within 7 postoperative days, it will be considered present in the case of KDIGO stage ≥ 2

    Measured: day 7 after surgery

  8. Quality of life assessed with an EQ5D test performed at day 30

    Quality of life assessed with an EQ5D test performed at day 30

    Measured: day 30 after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2026
  2. Study startDec 2026 (estimated)
  3. Primary completionMar 2029 (estimated)
  4. Study completionMar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
434 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07766109
Sponsor's protocol ID
RC31/25/0443
Other IDs
2025-524395-30-00, 2025
Acronym
DISCO
Status last verified
Nov 2026
First submitted
10 Aug 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing treatment discontinuation, treatment continuation and ketone levels in people with Heart Failure and Cardiac Surgery, run by University Hospital, Toulouse at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact François LABASTE, MD-PH (05 61 32 28 22 ext. +33, labaste.f@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postoperative cardiovascular outcomes (time frame: day 30 after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07766109.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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