[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100500538":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":34,"centralContacts":39,"locations":45,"responsibleParty":103,"collaborators":106,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":113,"sex":119,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":43,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":48,"whyStopped":43,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Göteborg University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Surgically Treated Primary Aldosteronism","ACTIVE_COMPARATOR","Standard therapy",[13],"Procedure: Unilateral adrenalectomy",{"label":15,"type":10,"description":16,"interventionNames":17},"Medically Treated Unilateral Primary Aldosteronism","Open label eplerenone treatment",[18],"Drug: Medical treatment (eplerenone)",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Unilateral adrenalectomy","Minimally invasive surgery is performed via the lateral transperitoneal approach or the posterior retroperitoneal approach, with or without robotic assistance, according to the surgeon's preference.",[9],[26],"Surgery",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Medical treatment (eplerenone)","The initial dose of eplerenone is 25 mg twice daily. The dose will be increased by 50 mg every fourth week until systolic blood pressure of 140 mmHg and diastolic blood pressure of 90 mmHg or lower has been reached and biochemical control (plasma renin above the middle of the reference range, i.e \\> \\~20 mIU\u002FL) is attained and\u002For hyperkalemia develops. The maximal dose of eplerenone is 300 mg twice daily.",[15],[33],"Mineralocorticoid receptor antagonists",[35],{"name":36,"affiliation":37,"role":38},"Oskar Ragnarsson, MD","Institute of Medicine, Sahlgrenska Academy, University of Gothenburg","PRINCIPAL_INVESTIGATOR",[40],{"name":36,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","00460313421000",null,"oskar.ragnarsson@medic.gu.se",[46,77,91],{"facility":47,"status":48,"city":49,"state":43,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"University of Gothenburg","RECRUITING","Gothenburg","41345","Sweden","SE",{"type":54,"coordinates":55},"Point",[56,57],11.96679,57.70716,{"lat":57,"lon":56},[60,63,67,70,72,73,75],{"name":61,"role":41,"phone":62,"phoneExt":43,"email":44},"Oskar Ragnarsson, MD, PHD","+46(0)707292228",{"name":64,"role":41,"phone":65,"phoneExt":43,"email":66},"Andreas Muth, MD,PHD","+46(0)3134210 00","andreas.muth@vgregion.se",{"name":68,"role":69,"phone":43,"phoneExt":43,"email":43},"Gudmundur Johannsson, Professor","SUB_INVESTIGATOR",{"name":71,"role":38,"phone":43,"phoneExt":43,"email":43},"Oskar Ragnarsson, MD,PHD",{"name":64,"role":69,"phone":43,"phoneExt":43,"email":43},{"name":74,"role":69,"phone":43,"phoneExt":43,"email":43},"Penelope Trimpou, MD,PHD",{"name":76,"role":38,"phone":43,"phoneExt":43,"email":43},"Eleftheria Gkaniatsa",{"facility":78,"status":79,"city":80,"state":43,"zip":43,"country":51,"countryCode":52,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Karolinska University Hospital, Stockholm, Sweden.","NOT_YET_RECRUITING","Stockholm",{"type":54,"coordinates":82},[83,84],18.06871,59.32938,{"lat":84,"lon":83},[87],{"name":88,"role":41,"phone":89,"phoneExt":43,"email":90},"Cristina Volpe, MD,PHD","0046-08-524 800 00","cristina.dahlqvist-volpe@regionstockholm.se",{"facility":92,"status":79,"city":93,"state":43,"zip":43,"country":51,"countryCode":52,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Umeå University, Umeå, Sweden.","Umeå",{"type":54,"coordinates":95},[96,97],20.25972,63.82842,{"lat":97,"lon":96},[100],{"name":101,"role":41,"phone":43,"phoneExt":43,"email":102},"Per Dahlqvist, MD, PHD","per.dahlqvist@umu.se",{"type":38,"investigatorFullName":104,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Oskar Ragnarsson","MD, PHD, Associate Professor",[107,109],{"name":108,"class":6},"Karolinska Institutet",{"name":110,"class":6},"Umeå University","100500538","unilateral-primary-aldosteronism-mineralocorticoid-antagonists-versus-surgical-treatment-100500538",false,"NCT05797558","Unilateral Primary Aldosteronism, Mineralocorticoid Antagonists Versus Surgical Treatment","Unilateral Primary Aldosteronism, Mineralocorticoid Antagonists Versus Surgical Treatment - A Randomized Controlled Trial","UPA-MEST","Inclusion Criteria:\n\n1. Patients with confirmed unilateral PA\n2. Age 18-70 years\n3. Candidate for surgical treatment\n4. No contraindications for minimally invasive surgery or treatment with MRA\n5. Understands oral and written information and provides oral and written informed consent.\n\nExclusion Criteria:\n\n1. Unwilling or unable to undergo surgery\n2. Unwilling to accept medical treatment for 12 months and not receiving standard treatment (surgery)\n3. Impaired renal function with eGFR \\\u003C45 ml\u002Fmin\u002F1,73m2\n4. P-cortisol \\>138 nmol\u002FL following 1-mg overnight dexamethasone suppression test.","ALL","18 Years","70 Years",{"count":123,"type":124},80,"ESTIMATED","INTERVENTIONAL",[127],"NA","This is a prospective randomized controlled trial where quality of life and the effectiveness of treatment will be evaluated in 80 patients with confirmed unilateral primary aldosteronism ,randomly assigned to be either treated surgically with unilateral adrenalectomy or to receive medical treatment with eplerenone.",[130],"Primary Hyperaldosteronism Due to Adrenal Adenoma",[132,133,134,135,136,137,138,139,140],"hyperaldosteronism","primary aldosteronism","lateralized aldosteronism","unilateral aldosteronism","eplerenone","spironolactone","randomized trial","quality of life","PASO outcomes","2025-04-03",{"date":143,"type":144},"2025-04-06","ACTUAL",{"date":146,"type":144},"2023-04-28",{"date":148,"type":124},"2028-05-28",{"name":5,"class":6},3]