[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527653":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":17,"studyPopulation":17,"armGroups":27,"interventions":46,"overallOfficials":62,"centralContacts":66,"locations":75,"responsibleParty":94,"collaborators":97,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":103,"sex":109,"minAge":110,"maxAge":17,"enrollmentInfo":111,"targetDuration":17,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":17,"overallStatus":78,"whyStopped":17,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Mayo Clinic","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Left Ventricular (LV) Fibrosis","LV fibrosis will be measured via indexed Extracellular Volume (iECV) which will be calculated as extracellular volume fraction (ECV%) x LV End Diastolic Volume Index as evaluated during Cardiac Magnetic Resonance Imaging (CMRI).","Baseline; Week 52",[14],{"measure":15,"description":16,"timeFrame":12},"Change in Exercise Capacity (peak VO2)","Change in Exercise Capacity will be evaluated based on peak VO2, measured as milliliters of oxygen per kilogram of body weight per minute (ml\u002Fkg\u002Fmin), during supine bike cardiopulmonary exercise test (Stress Echocardiogram).",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":23,"maskingDescription":17,"whoMasked":24},"DOUBLE",[25,26],"PARTICIPANT","INVESTIGATOR",[28,34,40],{"label":29,"type":30,"description":31,"interventionNames":32},"Losartan Group","EXPERIMENTAL","Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Losartan.",[33],"Drug: Losartan",{"label":35,"type":36,"description":37,"interventionNames":38},"Amlodipine Group","ACTIVE_COMPARATOR","Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Amlodipine.",[39],"Drug: Amlodipine",{"label":41,"type":42,"description":43,"interventionNames":44},"Placebo Group","PLACEBO_COMPARATOR","Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Placebo.",[45],"Drug: Placebo",[47,54,58],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"DRUG","Losartan","50mg administered orally once daily for 52 weeks.",[29],[53],"Cozaar",{"type":48,"name":55,"description":56,"armGroupLabels":57,"otherNames":17},"Amlodipine","5mg Amlodipine administered orally once daily for 52 weeks.",[35],{"type":48,"name":59,"description":60,"armGroupLabels":61,"otherNames":17},"Placebo","Oral capsules that contain no active drug ingredients administered orally once daily for 52 weeks.",[41],[63],{"name":64,"affiliation":5,"role":65},"Alexander Egbe, MBBS, MPH","PRINCIPAL_INVESTIGATOR",[67,72],{"name":68,"role":69,"phone":70,"phoneExt":17,"email":71},"ACHD Research Program","CONTACT","(507) 293-2565","RSTACHDRESPRG@mayo.edu",{"name":64,"role":69,"phone":73,"phoneExt":17,"email":74},"(507) 284-2520","Egbe.Alexander@mayo.edu",[76],{"facility":77,"status":78,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"Mayo Clinic in Rochester","RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":85,"coordinates":86},"Point",[87,88],-92.4699,44.02163,{"lat":88,"lon":87},[91,92,93],{"name":68,"role":69,"phone":70,"phoneExt":17,"email":71},{"name":64,"role":69,"phone":73,"phoneExt":17,"email":74},{"name":64,"role":65,"phone":17,"phoneExt":17,"email":17},{"type":65,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Alexander C. Egbe","Principal Investigator",[98],{"name":99,"class":100},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100527653","phase-3-a-study-of-angiotensin-ii-receptor-blocker-on-cardiovascular-remodeling-value-trial-100527653",false,"NCT06150560","A Study of Angiotensin-II Receptor Blocker on Cardiovascular Remodeling (VALUE Trial)","A Phase III, Randomized, Double-Blind, Placebo Controlled Clinical Trial Evaluating the Benefits and Mechanism Of Action Of Angiotensin-II Receptor Blocker On Cardiovascular Remodeling In Patients With Repaired Coarctation Of Aorta","VALUE","Inclusion Criteria:\n\n* B\u002FS1 hypertension\n* SBP 100-139 average based on 3 office measurements.\n* Age 18 or Older\n* Previous COA Repair\n\nExclusion Criteria:\n\n* Currently on beta blocker (BB) therapy\n* Pregnancy\u002Flactating\n* eGFR\\\u003C30\n* Hyperkalemia (serum potassium \\>5.5mmol\u002FL)\n* Severe Aortic or Mitral valve stenosis or regurgitation\n* Epicardial CAD diagnosis\n* Received antihypertensive medications within the past year","ALL","18 Years",{"count":112,"type":113},120,"ESTIMATED","INTERVENTIONAL",[116],"PHASE3","The purpose of this study is to evaluate the effectiveness and mechanism of action of Losartan in the treatment of coarctation of aorta.",[119,120],"Coarctation of Aorta","High Blood Pressure","2026-09-09",{"date":123,"type":124},"2026-09-11","ACTUAL",{"date":126,"type":124},"2024-04-01",{"date":128,"type":113},"2028-06-01",{"name":5,"class":6},1]