[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100432650":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":41,"studyPopulation":29,"armGroups":42,"interventions":55,"overallOfficials":63,"centralContacts":67,"locations":73,"responsibleParty":112,"collaborators":114,"id":116,"slug":29,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":117,"sex":123,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":29,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":136,"overallStatus":76,"whyStopped":29,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Institut universitaire de cardiologie et de pneumologie de Québec, University Laval","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Change in the anatomic progression of aortic stenosis","Aortic valve calcification (measured by MDCT)","Baseline, 2 years",[14,17,20,23,26],{"measure":15,"description":16,"timeFrame":12},"Change in peak aortic jet velocity","peak aortic jet velocity (Echocardiography)",{"measure":18,"description":19,"timeFrame":12},"Change in aortic valve area","Aortic valve area (Echocardiography)",{"measure":21,"description":22,"timeFrame":12},"Change in left ventricular (LV) dimension","LV dimension (Echocardiography, MRI)",{"measure":24,"description":25,"timeFrame":12},"Change in left ventricular (LV) mass","LV mass (Echocardiography, MRI)",{"measure":27,"description":28,"timeFrame":12},"Change in left ventricular (LV) fibrosis","LV Fibrosis (MRI)",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":29,"primaryPurpose":33,"observationalModel":29,"timePerspective":29,"maskingInfo":34},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":35,"maskingDescription":29,"whoMasked":36},"QUADRUPLE",[37,38,39,40],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Studies support the concept that activation of the renin-angiotensin system may be involved in the progression of valve stenosis and myocardial fibrosis in aortic stenosis. Furthermore recent studies have shown that renin-angiotensin system medication may slow down aortic stenosis progression rate and left ventricle remodeling.\n\nThus the present study is a randomized control trial to test the efficacy of the angiotensin receptor blocker (ARB) to slow down aortic stenosis progression and left ventricular remodeling\u002Fdysfunction in patients with mild-to-moderate aortic stenosis.",[43,49],{"label":44,"type":45,"description":46,"interventionNames":47},"Angiotensin Receptor Blockers","EXPERIMENTAL","Angiotensin Receptor Blockers will be given orally once a day for 2 years.",[48],"Drug: Angiotensin Receptor Blockers",{"label":50,"type":51,"description":52,"interventionNames":53},"Placebo","PLACEBO_COMPARATOR","Participants will receive a matched placebo orally once a day for 2 years.",[54],"Other: Placebo",[56,60],{"type":57,"name":44,"description":58,"armGroupLabels":59,"otherNames":29},"DRUG","Angiotensin Receptor Blockers treatment for 2 years.",[44],{"type":6,"name":50,"description":61,"armGroupLabels":62,"otherNames":29},"Placebo administration for 2 years.",[50],[64],{"name":65,"affiliation":5,"role":66},"Marie-Annick Clavel, PhD","PRINCIPAL_INVESTIGATOR",[68],{"name":65,"role":69,"phone":70,"phoneExt":71,"email":72},"CONTACT","418-656-8711","2678","Marie-Annick.Clavel@criucpq.ulaval.ca",[74,94],{"facility":75,"status":76,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"CRIUCPQ","RECRUITING","Québec","Quebec","G1V 4G5","Canada","CA",{"type":83,"coordinates":84},"Point",[85,86],-71.21454,46.81228,{"lat":86,"lon":85},[89,90,92],{"name":65,"role":69,"phone":70,"phoneExt":71,"email":72},{"name":29,"role":69,"phone":70,"phoneExt":91,"email":29},"3868",{"name":93,"role":69,"phone":29,"phoneExt":29,"email":29},"Marie-Annick Clavel",{"facility":95,"status":76,"city":96,"state":29,"zip":29,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Odense University Hospital","Odense","Denmark","DK",{"type":83,"coordinates":100},[101,102],10.38831,55.39594,{"lat":102,"lon":101},[105,109,111],{"name":106,"role":69,"phone":107,"phoneExt":29,"email":108},"Ali Mulham, MD","+4560677621","Mulham.Ali2@rsyd.dk",{"name":110,"role":69,"phone":29,"phoneExt":29,"email":29},"Jordi Sanchez Dahl, MD, PhD",{"name":106,"role":69,"phone":29,"phoneExt":29,"email":29},{"type":66,"investigatorFullName":93,"investigatorTitle":113,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Full Professor",[115],{"name":95,"class":6},"100432650",false,"NCT04913870","Angiotensin Receptor Blockers in Aortic Stenosis","Impact of Angiotensin Receptor Blockers in Aortic Stenosis - a Randomized Controlled Trial","ARBAS","Inclusion Criteria:\n\n* Mild to moderate aortic stenosis (peak aortic jet velocity ≥2.5 and \\\u003C4m\u002Fs)\n* Normal left ventricular ejection fraction (i.e. ≥50%)\n* Systolic blood pressure \\>110 mmHg\n* Diastolic blood pressure \\>70 mmHg\n\nExclusion Criteria:\n\n* More than mild aortic or mitral regurgitation, or mitral stenosis\n* Current use or documented indication for renin-angiotensin system medication or Aliskiren\n* Known allergy or intolerance to angiotensin II receptor blockers (ARBs)\n* Alzheimer, dementia or known non-compliant patient\n* Renal dysfunction (glomerular filtration rate \\\u003C30ml\u002Fmin\u002F1.73m2)\n* Chronic hyperkalemia\n* Diagnosed hepatic failure, cirrhosis, hepatitis or history of hepatic impairment\n* Newly diagnosed (\\\u003C2 months) or poorly controlled diabetes\n* Pre-existing obstructive coronary artery disease with CCS III-IV angina or recent myocardial infarction (\\\u003C3 months)\n* Pregnant or lactating women\n* Patients unable to read, understand or sign research consent","ALL","20 Years","99 Years",{"count":127,"type":128},144,"ESTIMATED","INTERVENTIONAL",[131],"PHASE4","This study is intended to investigate the effect of angiotensin receptor blockers (ARBs) on mild-to-moderate aortic stenosis.",[134,135],"Aortic Stenosis","Aortic Valve Stenosis",[137,138,139,140],"Angiotensin II Receptor Blockers","Left ventricular remodeling","Valvular heart disease","Aortic stenosis","2024-12-18",{"date":143,"type":144},"2024-12-20","ACTUAL",{"date":146,"type":144},"2020-02-01",{"date":148,"type":128},"2027-02",{"name":5,"class":6},2]