[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571069":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":51,"collaborators":53,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":18,"enrollmentInfo":66,"targetDuration":18,"studyType":69,"phases":70,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":34,"whyStopped":18,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"University of East Anglia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group: Empagliflozin + usual stroke care","EXPERIMENTAL","Patients randomised in this group will be taking the SLGT2 inhibitor (empagliflozin 10mg OD) in addition to usual stroke care",[13],"Drug: Empagliflozin 10 MG",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group: Usual stroke care alone","NO_INTERVENTION","Patients randomised in this group will continue to have their guideline directed stroke care",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Empagliflozin 10 MG","Participants allocated in the Intervention Group will be taking empagliflozin 10mg once a day in addition to their usual stroke care.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Vassilios S Vassiliou, PhD","CONTACT","01603592534","V.Vassiliou@uea.ac.uk",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Addenbrookes Hospital","RECRUITING","Cambridge","Cambridgeshire","CB2 0QQ","United Kingdom","UK",{"type":41,"coordinates":42},"Point",[43,44],0.11667,52.2,{"lat":44,"lon":43},[47],{"name":48,"role":28,"phone":49,"phoneExt":29,"email":50},"Vassilios S. Vassiliou, PhD","07443911905","v.vassiliou@uea.ac.uk",{"type":52,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[54],{"name":55,"class":56},"Addenbrookes Hospital, Cambridge","UNKNOWN","100571069","phase-2-empa-esus-a-randomised-control-trial-to-investigate-the-impact-of-empagliflozin-on-left-atrial-function-in-patients-with-embolic-stroke-of-undetermined-source-100571069",false,"NCT06715449","EMPA-ESUS. a Randomised Control Trial to Investigate the Impact of Empagliflozin on Left Atrial Function in Patients with Embolic Stroke of Undetermined Source","EMPA-ESUS","Inclusion Criteria:\n\n* Age over 18 years\n* Patient has had an embolic stroke of undetermined source, defined as:\n\n  * Ischaemic stroke or transient ischaemic attack diagnosed clinically + supporting radiological features on CT or MRI imaging\n  * No clinically significant extracranial or intracranial atherosclerosis found on neck imaging\n  * No evidence of prevalent cardioembolic source of embolism - atrial dysrhythmia, cardiac thrombus, prosthetic valve, cardiac tumours, mitral stenosis, recent MI, LVEF\\\u003C35%, valvular vegetations, or infective endocarditis\n\nAND\n\n* No other specific stroke aetiology identified (pro-thrombotic states, arteritis, dissection, drug abuse)\n* Patient has been referred for an implantable loop recorder implant to investigate possible atrial dysrhythmia\n* Ability to give written, informed consent\n\nExclusion Criteria:\n\n* Prevalent atrial fibrillation or atrial flutter\n* Subsequent demonstration of a cardio-emoblic source\n* Pre-existent indication for SGLT2i including heart failure with a reduced ejection fraction and Type 1 or Type 2 diabetes mellitus\n* Contraindication to the commencement of SGLT2i including a history of, or risk factors for diabetic ketoacidosis, such as restricted food intake or a history of alcohol abuse\n* Hypersensitivity to the active substance or to any of the excipients of empagliflozin\n* Presence of alternate implantable cardiac devices such as a pacemaker or defibrillator, that would make ILR utilisation redundant\n* Any condition that may confound the results or interfere with participation such as dementia\n* An unwillingness to participate","ALL","18 Years",{"count":67,"type":68},100,"ESTIMATED","INTERVENTIONAL",[71,72],"PHASE2","PHASE3","Atrial fibrillation (AF) is the most common heart rhythm problem in the adult population. There is a five-fold increase in stroke risk in patients with AF. Whilst there has been considerable advances in AF management including improvement in ablation therapy, preventing AF remains an unmet need.\n\nOne promising avenue is a group of medications called Sodium Glucose Cotransporter 2 (SGLT2) inhibitors, which has been studied in people with diabetes, kidney disease and weak heart muscle. These medicines were consistently found to lower the risk of developing AF. This can be promising for patients who have suffered a stroke for unclear reasons, where a significant proportion are subsequently found to have short periods of AF. Often prior to AF development, patients may have changes in the structure or function of the top chambers of their heart (the atria). This may provide a useful marker for us to understand whether SGLT2i impacts AF risk.\n\nAim of research study:\n\nThe aim of this study is to investigate whether the use of the drug empagliflozin, an SGLT2 inhibitor, prevents changes in the left atrium associated with future AF development. Using advanced imaging techniques and continuous rhyth monitoring we intend to study the effect of SGLT2 inhibitors on left atrial function and arrhythmia occurence.\n\nStudy design:\n\nPatients who are undergoing an implantable loop recorder insertion, to detect AF following a stroke, will be invited for participation. Eligible consenting patients will have a baseline assessment with echocardiography, electrocardiogram and anthropometric measures. They will then be randomised to receive either the SGLT2i alongside usual stroke care for 6 months, or usual stroke care alone. All patients will be monitored remotely via their loop recorder, and will undergo repeat electrocardiogpahic, echocardiographic and anthropometric assessment at 6 months. This way, we aim to investigate whether the SGLT2 inhibitor causes changes in atrial parameters that may be associated with future AF development.",[75,76],"Embolic Stroke of Undetermined Source","Atrial Fibrillation New Onset",[78],"Atrial strain","2024-11-28",{"date":81,"type":82},"2024-12-04","ACTUAL",{"date":84,"type":82},"2024-11-22",{"date":86,"type":68},"2029-03",{"name":5,"class":6},1]