[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651796":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":36,"centralContacts":41,"locations":51,"responsibleParty":67,"collaborators":26,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":26,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":92,"whyStopped":26,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"University Hospital, Toulouse","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Continuation of SGLT-2 Inhibitors Before Cardiac Surgery","EXPERIMENTAL","patients who continue SGLT-2 inhibitors preoperatively",[13,14],"Drug: treatment continuation","Diagnostic Test: ketone levels",{"label":16,"type":6,"description":17,"interventionNames":18},"Discontinuation of SGLT-2 Inhibitors Before Cardiac Surgery","patients who discontinue SGLT-2 inhibitors 3 days before surgery",[19,14],"Drug: treatment discontinuation",[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","treatment discontinuation","stop the SGLT-2 inhibitors treatment (dapagliflozine or empagliflozine) 3 days before surgery",[16],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"treatment continuation","maintain SGLT-2i treatment (dapagliflozine or empagliflozine) until surgery morning included",[9],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":26},"DIAGNOSTIC_TEST","ketone levels","Measurement of capillary ketone levels",[9,16],[37],{"name":38,"affiliation":39,"role":40},"François LABASTE, MD_PH","University Hospital of Toulouse","PRINCIPAL_INVESTIGATOR",[42,48],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"François LABASTE, MD-PH","CONTACT","05 61 32 28 22","+33","labaste.f@chu-toulouse.fr",{"name":49,"role":44,"phone":26,"phoneExt":26,"email":50},"Magali CENTELLES","centelles.m@chu-toulouse.fr",[52],{"facility":53,"status":26,"city":54,"state":26,"zip":26,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"University Hospital of TOULOUSE","Toulouse","France","FR",{"type":58,"coordinates":59},"Point",[60,61],1.44367,43.60426,{"lat":61,"lon":60},[64,65,66],{"name":43,"role":44,"phone":26,"phoneExt":26,"email":47},{"name":49,"role":44,"phone":26,"phoneExt":26,"email":50},{"name":43,"role":40,"phone":26,"phoneExt":26,"email":26},{"type":68,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100651796","phase-4-discontinuation-or-continuation-of-sglt-2-inhibitors-before-cardiac-surgery-100651796",false,"NCT07766109","Discontinuation or Continuation of SGLT-2 Inhibitors Before Cardiac Surgery","Discontinuation or Continuation of SGLT-2 Inhibitors Before Cardiac Surgery: Impact on Postoperative Cardiovascular Outcomes - DISCO Study","DISCO","Inclusion Criteria:\n\n* Adult patients scheduled to undergo cardiac surgery with cardiopulmonary bypass\n* patients treated with SGLT-2 inhibitors, including combined treatment with metformin, for at least 4 weeks\n* heart failure patients with a left ventricular ejection fraction strictly below 50%\n* patients enrolled in a social security scheme or equivalent\n* patients who have signed the informed consent form\n\nExclusion Criteria:\n\n* Treatment with SGLT-2 inhibitors initiated less than 4 weeks ago and other than empagliflozine or dapagliflozine\n* 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\u002Fmin\u002F1.73 m²\n* 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\u002FL within 7 days prior to inclusion); acute kidney injury within the previous 7 days (KDIGO stage ≥2); severe hepatocellular failure (factor V level \\\u003C 50%); acute alcohol intoxication within the previous 7 days or active alcohol use disorder without withdrawal\n* surgery scheduled within less than 3 days\n* surgery for active endocarditis within the last 3 months\n* patients on preoperative mechanical circulatory support\n* heart transplant surgery or implantation of an LVAD (left ventricular assist device)\n* chronic kidney disease patients with a glomerular filtration rate below 25 mL\u002Fmin\u002F1.73m²\n* heart failure patients with a preserved ejection fraction, equal to or greater than 50\n* pregnant or breastfeeding women\n* minors or adults under legal protection (guardianship or conservatorship)\n* patients participating in another interventional study patients who do not understand or speak French.","ALL","18 Years",{"count":80,"type":81},434,"ESTIMATED","INTERVENTIONAL",[84],"PHASE4","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.",[87,88],"Heart Failure","Cardiac Surgery",[90,91],"perioperative care","SGLT-2 inhibitor","NOT_YET_RECRUITING","2026-08-10",{"date":95,"type":96},"2026-08-14","ACTUAL",{"date":98,"type":81},"2026-10",{"date":100,"type":81},"2029-01",{"name":5,"class":6},1]