[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577889":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":11,"studyPopulation":11,"armGroups":26,"interventions":37,"overallOfficials":46,"centralContacts":51,"locations":58,"responsibleParty":78,"collaborators":11,"id":82,"slug":11,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":11,"enrollmentInfo":90,"targetDuration":11,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":11,"overallStatus":61,"whyStopped":11,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"University of Luebeck","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Time until first occurrence of",null,"7 Years",[14],{"measure":15,"description":16,"timeFrame":12},"Safety endpoints","* AE (general)\n* AE leading to treatment discontinuation\n* SAE\n* AE of special interest (AESI): including volume depletion, hypotension, metabolic acidosis and ketoacidosis",{"allocation":18,"interventionModel":19,"interventionModelDescription":11,"primaryPurpose":20,"observationalModel":11,"timePerspective":11,"maskingInfo":21},"RANDOMIZED","FACTORIAL","TREATMENT",{"masking":22,"maskingDescription":11,"whoMasked":23},"DOUBLE",[24,25],"PARTICIPANT","CARE_PROVIDER",[27,32],{"label":28,"type":29,"description":11,"interventionNames":30},"SGLT2 Arm","EXPERIMENTAL",[31],"Drug: SGLT2",{"label":33,"type":34,"description":11,"interventionNames":35},"Placebo","PLACEBO_COMPARATOR",[36],"Drug: Placebo",[38,43],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":11},"DRUG","SGLT2","10 mg",[28],{"type":39,"name":33,"description":44,"armGroupLabels":45,"otherNames":11},"1 tablet",[33],[47],{"name":48,"affiliation":49,"role":50},"Ingo Eitel, Prof. Dr.","Universitätsklinikum Schleswig-Holstein - Campus Lübeck","PRINCIPAL_INVESTIGATOR",[52,56],{"name":48,"role":53,"phone":54,"phoneExt":11,"email":55},"CONTACT","045150044542","cvro@uksh.de",{"name":57,"role":53,"phone":11,"phoneExt":11,"email":11},"Elias Rawish, Dr.",[59],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Universität zu Lübeck","RECRUITING","Lübeck","Schleswig-Holstein","23538","Germany","DE",{"type":68,"coordinates":69},"Point",[70,71],10.68729,53.86893,{"lat":71,"lon":70},[74,76],{"name":75,"role":53,"phone":11,"phoneExt":11,"email":11},"Ingo Eitel, Prof. Dr. med.",{"name":77,"role":53,"phone":11,"phoneExt":11,"email":11},"Thomas Stiermaier, Dr.med",{"type":79,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Prof. Dr. med. Ingo Eitel","Head of department of medical clinic II","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":91,"type":92},3000,"ESTIMATED","INTERVENTIONAL",[95],"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.",[98],"Atrial Hypertension","2025-12-15",{"date":101,"type":102},"2025-12-22","ACTUAL",{"date":104,"type":102},"2025-12-10",{"date":106,"type":92},"2032-05-30",{"name":80,"class":6},1]