[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100466862":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":44,"responsibleParty":60,"collaborators":11,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":11,"enrollmentInfo":73,"targetDuration":11,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":11,"overallStatus":47,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Herlev and Gentofte Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dapagliflozin 10 mg once daily","EXPERIMENTAL",null,[13],"Drug: Dapagliflozin 10 mg",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo once daily","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Dapagliflozin 10 mg","The intervention arm consists of dapagliflozin 10 mg orally once daily",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Placebo","The comparator arm consists of placebo orally once daily",[15],[30],{"name":31,"affiliation":32,"role":33},"Tor Biering-Sørensen","Research Director","STUDY_CHAIR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"Katja Vu Bartholdy, MD","CONTACT","+4531360232","katja.vu.bartholdy@regionh.dk",{"name":41,"role":37,"phone":42,"phoneExt":11,"email":43},"Niklas Dyrby Johansen","+4520204794","niklas.dyrby.johansen@regionh.dk",[45],{"facility":46,"status":47,"city":48,"state":11,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Gentofte Hospital","RECRUITING","Copenhagen","2900","Denmark","DK",{"type":53,"coordinates":54},"Point",[55,56],12.56553,55.67594,{"lat":56,"lon":55},[59],{"name":36,"role":37,"phone":11,"phoneExt":11,"email":11},{"type":61,"investigatorFullName":31,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Research Director, MD, PhD, MPH","100466862","phase-2-effects-of-dapagliflozin-on-echocardiographic-measures-of-cardiac-structure-and-function-in-patients-with-ckd-100466862",false,"NCT05359263","Effects of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients with CKD","A 6-Month, Randomized, Double-Blind Study to Evaluate the Effect of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients with Chronic Kidney Disease","DECODE-CKD","Inclusion Criteria:\n\n* Signed informed consent\n* ≥ 18 years of age\n* Chronic kidney disease (CKD), defined as evidence of decreased eGFR (eGFR ≥20 and \\\u003C60 mL\u002Fminute per 1.73 m2) or between eGFR ≥60 and \\\u003C90 mL\u002Fminute per 1.73 m2 with urinary albumin:creatinine ratio ≥200 mg\u002Fg or protein:creatinine ratio ≥300 mg\u002Fg\n* Stable treatment with clinically appropriate doses of ACEi\u002FARB among CKD patients with proteinuria and uptitrated to maximal recommended or tolerated dose for at least 4 weeks before randomization, if not medically contraindicated\n* For patients with type 2 diabetes:\n\nStable antihyperglycemic treatment \\> 30 days before screening\n\n* Female patients should either not be of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing one of the following methods of contraception throughout the study and for 30 days after study completion: Hormonal contraception (oral contraceptives, contraceptive implant, injectable birth control, contraceptive patch, or vaginal ring) or intrauterine device\n* Ability to understand and read Danish\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* For patients with type 2 diabetes:\n\nHistory of diabetic ketoacidosis\n\n* Patients undergoing dialysis\n* History of organ transplant\n* Treatment with SGLT2 inhibitor within 8 weeks prior to enrolment\n* Known allergy or hypersensitivity to SGLT2 inhibitors or Placebo ingredients\n* Myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks of enrolment\n* Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair\u002Freplacement within 12 weeks prior to enrolment\n* Any condition outside the renal and cardiovascular study area with a life expectancy of \\\u003C2 years based on investigator's clinical judgement\n* Hepatic impairment (aspartate transaminase or alanine transaminase \\>3 times the upper limit of normal \\[ULN\\] or total bilirubin \\>2 times the ULN at the time of enrolment)\n* Known blood-borne diseases, such as Hepatitis A, B, C, D, and E, and Human immunodeficiency virus (HIV) types 1 and 2, Ebola, Lassa fever virus.\n* Female patients who are pregnant, lactating, or are considering becoming pregnant during the study or for 6 months after study completion\n* Participation in another clinical study with an investigational product within the last month prior to enrolment\n* Inability to understand or comply with the investigational product, procedures, and\u002For follow-up or any conditions that may prevent the participant to complete the study","ALL","18 Years",{"count":74,"type":75},222,"ESTIMATED","INTERVENTIONAL",[78],"PHASE2","The purpose of this study is to investigate the effects of dapagliflozin on echocardiographic measures of cardiac structure and function in patients with chronic kidney disease.",[81],"Chronic Kidney Diseases","2025-02-06",{"date":84,"type":85},"2025-02-10","ACTUAL",{"date":87,"type":85},"2022-06-08",{"date":89,"type":75},"2025-02-18",{"name":31,"class":6},1]