[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100384492":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":37,"centralContacts":41,"locations":51,"responsibleParty":68,"collaborators":70,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":19,"enrollmentInfo":97,"targetDuration":19,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":19,"overallStatus":54,"whyStopped":19,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"National Heart Centre Singapore","OTHER",[8,15],{"label":9,"type":6,"description":10,"interventionNames":11},"Intensive Treatment Group","High dose of RAASi and beta-blockers (unless contraindicated) as well as preferential use of SGLT2i as per local drug label guidelines on top of standard therapy.",[12,13,14],"Drug: Renin-angiotensin-aldosterone system inhibitors","Drug: Beta blocker","Drug: SGLT2 Inhibitor - Sodium Glucose Cotransporter Subtype 2 Inhibitor Product",{"label":16,"type":17,"description":18,"interventionNames":19},"Control Group","NO_INTERVENTION","Standard therapy where the use of SGLT2i at randomization is not encouraged but RAASi and beta-blockers (except for maximal dosage) are allowed. Prescription or up-titration of the study drugs listed under Intensive Treatment is not encouraged. If investigators\u002Ftreating physicians feel that further prescription or up-titration is required, a thorough justification is mandatory. Unless there is clinically irrefutable reason, every attempt should be made to use other blood pressure lowering drugs than RAASi or beta-blockers, as well as glucose lowering drugs than SGLT2i, in the control group.",null,[21,29,32],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Renin-angiotensin-aldosterone system inhibitors","Research participants in the intensive therapy arm should be strongly encouraged to follow the intensive treatment strategy. Every attempt should be made to up-titrate RAS-antagonists and beta-blockers (max dosage, unless contraindicated) as well as preferentially use SGLT2i (standard dosage, as required) throughout the trial.",[9],[27,28],"Angiotensin-converting enzyme (ACE) inhibitors","Angiotensin II receptor blockers (ARBs)",{"type":22,"name":30,"description":24,"armGroupLabels":31,"otherNames":19},"Beta blocker",[9],{"type":22,"name":33,"description":24,"armGroupLabels":34,"otherNames":35},"SGLT2 Inhibitor - Sodium Glucose Cotransporter Subtype 2 Inhibitor Product",[9],[36],"SGLT2 inhibitors",[38],{"name":39,"affiliation":5,"role":40},"Carolyn Lam Prof","STUDY_DIRECTOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":19,"email":46},"Serene Ng Miss","CONTACT","67042232","serene.ng.b.l@singhealth.com.sg",{"name":48,"role":44,"phone":49,"phoneExt":19,"email":50},"Salma Asali Miss","67042303","asali.salma@singhealth.com.sg",[52],{"facility":53,"status":54,"city":55,"state":19,"zip":56,"country":55,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Singapore General Hospital (SGH)","RECRUITING","Singapore","169608","SG",{"type":59,"coordinates":60},"Point",[61,62],103.85007,1.28967,{"lat":62,"lon":61},[65],{"name":66,"role":44,"phone":67,"phoneExt":19,"email":46},"Serene Ng, Ms","(+65) 6704 2232",{"type":69,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[71,73,75,77,79,81,83,86],{"name":72,"class":6},"Singapore General Hospital",{"name":74,"class":6},"Mackay Memorial Hospital",{"name":76,"class":6},"National Taiwan University Hospital",{"name":78,"class":6},"Peking University People's Hospital",{"name":80,"class":6},"Medanta, The Medicity, India",{"name":82,"class":6},"Public Health Foundation of India",{"name":84,"class":85},"Putrajaya Hospital, Malaysia","UNKNOWN",{"name":87,"class":6},"Universiti Teknologi Mara","100384492","phase-4-asian-diabetes-outcomes-prevention-trial-100384492",false,"NCT04286399","Asian Diabetes Outcomes Prevention Trial","ADOPT","Inclusion Criteria:\n\n* Type 2 diabetes for at least six months\n* ≥ 40 years of age, men or women\n* No known cardiovascular disease ( defined as known coronary stenosis \\> 70%, reduced left ventricular ejection fraction \\\u003C 40%, or a history of myocardial infarction\u002F coronary revascularization\u002F heart failure hospitalization\u002F stroke\u002F prior non-traumatic lower limb amputation or angioplasty)\n* NT-proBNP \\> 125 pg\u002FmL\n* Written informed consent\n\nExclusion Criteria:\n\n* History of hypersensitivity to any of the drugs investigated as well as known or suspected contraindications to the study drugs or previous history of intolerance\n* Patients already on a maximum dose of RAASi or beta-blocker\n* History of DM ketoacidosis\u002FType 1 DM\n* eGFR \\\u003C 45ml\u002Fmin\u002F1.73m2\n* Symptomatic hypotension and\u002For Visit 1 systolic blood pressure (SBP) \\\u003C 100mmHg.\n* Symptomatic bradycardia, high-grade AV blocks (Grade 2 and 3) and\u002For Visit 1 heart rate (HR) \\\u003C 60bpm.\n* Any disease other than diabetes lowering the patient's life expectancy to less than two years.\n* Chronic infections (E.g. chronic cystitis, recurrent urinary tract infections) or malignancies or uncontrolled thyroid disorder or liver disease\n* Systemic treatment with corticosteroids.\n* Pregnant or nursing women\n* Any other clinical condition that might affect patients' safety during trial, at the investigator's discretion.\n* Participation in an investigational drug trial","ALL","40 Years",{"count":98,"type":99},2400,"ESTIMATED","INTERVENTIONAL",[102],"PHASE4","The aim of this study is to identify patients with DM at high risk of CVD using elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (\\>125pg\u002FmL), and (2) intensify therapy using renin-angiotensin system (RAS) antagonists, beta-blockers and sodium glucose co-transporter-2 inhibitors (SGLT2i) for primary prevention of cardiovascular events in this high-risk DM population.",[105,106],"Diabetes Mellitus","Cardiovascular Diseases","2021-04-28",{"date":109,"type":110},"2021-04-30","ACTUAL",{"date":112,"type":110},"2019-07-01",{"date":114,"type":99},"2034-06-30",{"name":5,"class":6},1]