A Phase 4 interventional study of treatment discontinuation and treatment continuation in Heart Failure and Cardiac Surgery, sponsored by University Hospital, Toulouse. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by University Hospital, Toulouse · Phase 4, Interventional, and Treatment
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.
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 434 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients who continue SGLT-2 inhibitors preoperatively
Drug: treatment continuation · Diagnostic Test: ketone levels
patients who discontinue SGLT-2 inhibitors 3 days before surgery
Drug: treatment discontinuation · Diagnostic Test: ketone levels
stop the SGLT-2 inhibitors treatment (dapagliflozine or empagliflozine) 3 days before surgery
maintain SGLT-2i treatment (dapagliflozine or empagliflozine) until surgery morning included
Measurement of capillary ketone levels
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
Time frame: day 30 after surgery
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
Time frame: day 2 after surgery
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
Time frame: day 7 after surgery
Rehospitalization
Rehospitalization within 30 days post-surgery for left heart failure
Time frame: day 30 after surgery
mortality
All-cause mortality
Time frame: day 7 after surgery
mortality
All-cause mortality
Time frame: day 30 after surgery
Euglycemic diabetic ketoacidosis
Euglycemic diabetic ketoacidosis
Time frame: day 7 after surgery
Acute kidney injury
Acute kidney injury within 7 postoperative days, it will be considered present in the case of KDIGO stage ≥ 2
Time frame: day 7 after surgery
Quality of life assessed with an EQ5D test performed at day 30
Quality of life assessed with an EQ5D test performed at day 30
Time frame: day 30 after surgery
Start is estimated for Dec 2026; primary completion for Mar 2029, 27 months later.
Of 164 non-industry phase 4 interventional studies under Heart Failure, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 56. This study's planned 27 months is below that.
Counting every sponsor, half of 183 studies reached it within 31 months; a quarter within 22 and three quarters within 56.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 5, 2026: start Oct 2026 → Dec 2026, primary completion Jan 2029 → Mar 2029 and completion Jan 2029 → Mar 2029.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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