[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577889":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":33,"locations":40,"responsibleParty":60,"collaborators":11,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":11,"enrollmentInfo":73,"targetDuration":11,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":11,"overallStatus":43,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"University of Luebeck","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SGLT2 Arm","EXPERIMENTAL",null,[13],"Drug: SGLT2",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","SGLT2","10 mg",[9],{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":11},"1 tablet",[15],[29],{"name":30,"affiliation":31,"role":32},"Ingo Eitel, Prof. Dr.","Universitätsklinikum Schleswig-Holstein - Campus Lübeck","PRINCIPAL_INVESTIGATOR",[34,38],{"name":30,"role":35,"phone":36,"phoneExt":11,"email":37},"CONTACT","045150044542","cvro@uksh.de",{"name":39,"role":35,"phone":11,"phoneExt":11,"email":11},"Elias Rawish, Dr.",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Universität zu Lübeck","RECRUITING","Lübeck","Schleswig-Holstein","23538","Germany","DE",{"type":50,"coordinates":51},"Point",[52,53],10.68729,53.86893,{"lat":53,"lon":52},[56,58],{"name":57,"role":35,"phone":11,"phoneExt":11,"email":11},"Ingo Eitel, Prof. Dr. med.",{"name":59,"role":35,"phone":11,"phoneExt":11,"email":11},"Thomas Stiermaier, Dr.med",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Prof. Dr. med. Ingo Eitel","Head of department of medical clinic II","100577889","phase-3-sglt2-inhibition-for-cardiovascular-endpoint-reduction-in-hypertension-100577889",false,"NCT06804161","SGLT2 Inhibition for Cardiovascular Endpoint Reduction in Hypertension","SGLT2-HYPE","Inclusion Criteria:\n\n1. Age ≥60 years\n2. Systolic blood pressure \\>140 mmHg or diastolic blood pressure \\>90 mmHg in two measurements on different days for newly diagnosed hypertension, or through one measurement at the screening visit for patients with an existing diagnosis of hypertension.\n3. A history of at least one CV event (myocardial infarction\\* or stroke\\*; stable angina or clinical evidence of coronary heart disease; peripheral arterial disease; transient ischemic attack)\n\nor\n\nThe presence of at least one cardiovascular risk factor (current smoking of more than one cigarette per day during at least 1 year; LDL-cholesterol \\> 4,0 mmol\u002Fl, Age ≥ 75 years, ESC HeartScore \\> 15%, BMI \\> 32 kg\u002Fm2)\n\n\\*excluding patients with myocardial infarction or stroke within preceding 3 months\n\nExclusion Criteria:- Known secondary cause of hypertension\n\n* Myocardial infarction or stroke within the previous 3 months\n* Symptomatic heart failure (including HFrEF, HFmEF, HFpEF)\n* History of Diabetes mellitus\n* History of ketoacidosis\n* Hepatic impairment (aspartate transaminase \\[AST\\] or alanine transaminase \\[ALT\\] \\>3x the upper limit of normal \\[ULN\\])\n* eGFR \\\u003C25 mL\u002Fmin\u002F1.73 m2 (CKD-EPICr 2021 formula) at Visit 1\n* Receiving therapy with an SGLT2i within 8 weeks prior to randomization or previous intolerance to an SGLT2i\n* Participation in another clinical study with an investigational product during the last month prior to enrolment\n* Known allergy or hypersensitivity to SGLT2i\n* Women who are pregnant, nursing, or who plan to become pregnant while in the trial\n* Any medical condition - outside the renal and CV disease area - with a life expectancy of less than 2 years based on investigator's clinical judgement\n* Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma)\n* Inability to give informed consent","ALL","60 Years",{"count":74,"type":75},3000,"ESTIMATED","INTERVENTIONAL",[78],"PHASE3","Hypertension (HTN) is a leading cause of cardiovascular disease (CVD). Despite existing therapies, patients with HTN still face substantial risks, due to pre-existing and ongoing end-organ damage due, in part, to inadequate blood pressure (BP) control. SGLT2 inhibitors (SGLT2i) are recommended for both type-2 diabetes and heart failure to reduce morbidity and mortality. SGLT2i reduce BP and might also improve outcomes for HTN by reducing end-organ damage through diverse other actions. However, confirmation that SGLT2i are clinically useful for the management of HTN is required to change guidelines and clinical practice.",[81],"Atrial Hypertension","2025-12-15",{"date":84,"type":85},"2025-12-22","ACTUAL",{"date":87,"type":85},"2025-12-10",{"date":89,"type":75},"2032-05-30",{"name":62,"class":6},1]