[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573020":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":20,"locations":30,"responsibleParty":56,"collaborators":10,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":10,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Medical University of Gdansk","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Post-DXM ARR development cohort",null,"Data from the first half of participants data will be used to generate post-DXM ARR (and possibly Ald) thresholds, which will be subsequently temporally validated in the confirmatory cohort.",{"label":13,"type":10,"description":14,"interventionNames":10},"Post-DXM ARR confirmatory cohort","Post-DXM ARR thresholds will be applied among participants of the confirmatory cohort, however, these will also undergo the medication withdrawal, OSLT, and other PA confirmatory tests if indicated.",[16],{"name":17,"affiliation":18,"role":19},"Piotr Kmiec, MD, Ph.D.","Department of Endocrinology and Internal Medicine, Medical University of Gdansk","PRINCIPAL_INVESTIGATOR",[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Piotr Kmiec, M.D., Ph.D.","CONTACT","0048 585844809","piotrkmiec@gumed.edu.pl",{"name":27,"role":23,"phone":28,"phoneExt":10,"email":29},"Renata Swiatkowska-Stodulska, Professor, MD, Ph.D.","0049 585844800","rensto@gumed.edu.pl",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Department of Endocrinology and Internal Medicine, University Clinical Center, Medical University of Gdansk","RECRUITING","Gdansk","Pomeranian Voivodeship","80214","Poland","PL",{"type":40,"coordinates":41},"Point",[42,43],18.64912,54.35227,{"lat":43,"lon":42},[46,47,49,50,52,54],{"name":17,"role":23,"phone":24,"phoneExt":10,"email":25},{"name":27,"role":23,"phone":48,"phoneExt":10,"email":29},"0048 58 5844800",{"name":17,"role":19,"phone":10,"phoneExt":10,"email":10},{"name":27,"role":51,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"name":53,"role":51,"phone":10,"phoneExt":10,"email":10},"Malgorzata Zdrojewska, MD, Ph.D.",{"name":55,"role":51,"phone":10,"phoneExt":10,"email":10},"Dominika Okroj, MD",{"type":57,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100573020","overnight-dexamethasone-in-primary-aldosteronism-screening-100573020",false,"NCT06740838","Overnight Dexamethasone in Primary Aldosteronism Screening","Overnight Dexamethasone in Primary Aldosteronism Screening in Patients on Interfering Therapy (the ODEPRASC Study)","ODEPRASC","Inclusion Criteria:\n\n* suspected or diagnosed HT,\n* age between 40 and 75,\n* available aldosterone and renin result at the time of one-day clinic stay,\n* scheduled 1-mg-DXM test (indicated for possible mild autonomous cortisol secretion, MACS),\n* presence of an adrenal lesion with radiologic features of adrenocortical adenoma\u002Fhyperplasia.\n\nExclusion Criteria:\n\n* baseline (pre-DXM) hyperreninemia (renin exceeding the upper limit of normal at the study site, i.e. 46.1 mIU\u002Fl, assay manufacturer: Diasorin),\n* baseline (pre-DXM) Ald\\\u003C3 ng\u002Fdl,\n* overt clinical and\u002For biochemical features of adrenal hormone deficiency or excess other than MACS (8 a.m. cortisolemia in the 50-140 nmol\u002Fl range in the 1-mg DXM test),\n* therapy with glucocorticoids, non-steroidal anti-inflammatory drugs, hormonal replacement therapy, hormonal contraceptive therapy, and\u002For licorice intake,\n* established or suspected secondary HT other than due to PA,\n* comorbidities including: poorly controlled and\u002For other than type 2 diabetes mellitus (T2DM), present and past alcohol abuse, obesity grade 3 (i.e. body mass index of at least 40 kg\u002Fm2), severe CV disease disqualifying a patient from chronic medication modification, active malignancy, decompensated autoimmune disease as well as an autoimmune disease associated with cardiovascular and\u002For renal complications, estimated glomerular filtration rate (eGFR) below 45 ml\u002Fmin\u002F1.73m2, poor physical condition, lack and withdrawal of consent for participation.","ALL","40 Years","75 Years",{"count":70,"type":71},240,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn whether screening for primary aldosteronism can be improved among patients on chronic blood pressure-lowering medications by ordering intake of 1 mg of dexamethasone prior to hormonal examinations.\n\nPrimary aldosteronism is a condition, in which an adrenal gland steroid aldosterone is released in excessive amounts; it commonly causes hypertension but requires specific therapy different from usually prescribed in other forms of hypertension.\n\nDexamethasone is a synthetic steroid used for both therapeutic and diagnostic purposes. A single 1 mg dexamethasone dose taken at 11 p.m. in order to measure hormone concentrations the following morning (so called overnight 1-mg dexamethasone test) is a commonly applied test in the work-up of adrenal disorders.\n\nThe main question the project aims to answer is:\n\nCan screening for primary aldosteronism be improved among patients receiving blood pressure-lowering medications with overnight 1-mg dexamethasone intake?\n\nParticipants will undergo changes in their chronic medication to be able to definitely rule out or confirm primary aldosteronism in blood hormonal examinations. These modifications and modifications are not part of the research project.\n\nFor this project participants will be asked to\n\n* undergo the 1-mg dexamethasone test one to three times in order to compare hormonal concentrations before and after it,\n* collect urine for 24 hours to determine aldosterone in the urine sample after medications interfering in aldosterone release are temporarily withdrawn.",[75,76],"Primary Aldosteronism","Hypertension",[78,79,80,81,82,83,84],"primary aldosteronism","screening","renin","aldosterone","hypertension","corticotropin","dexamethasone","2025-09-27",{"date":87,"type":88},"2025-10-02","ACTUAL",{"date":90,"type":88},"2024-10-22",{"date":92,"type":71},"2026-10-31",{"name":5,"class":6},1]