[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606700":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":37,"locations":42,"responsibleParty":68,"collaborators":25,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":25,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":25,"enrollmentInfo":80,"targetDuration":25,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":25,"overallStatus":90,"whyStopped":25,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"University Medical Centre Ljubljana","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Potassium-enriched salt-substitute arm","EXPERIMENTAL","The patients in this arm will use potassium-enriched salt-substitutes for cooking and seasoning food in their home environment.",[13],"Other: Potassium-enriched salt-substitute",{"label":15,"type":16,"description":17,"interventionNames":18},"Regular table salt arm","SHAM_COMPARATOR","The patients in this arm will use regular table salt for cooking and seasoning food in their home environment.",[19],"Other: Regular table salt",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Potassium-enriched salt-substitute","The patients in the experimental group will use potassium-enriched salt-substitutes for cooking and seasoning food in their home environment. Potassium-enriched salt-substitutes will contain 25% potassium chloride nad 75% sodium chloride.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Regular table salt","Patients in this arm will use regular table salt (100 % sodium chloride) for cooking and seasoning food in their home environment.",[15],[31,34],{"name":32,"affiliation":5,"role":33},"Tanja Belcic Mikic, MD, PhD, FEBTM","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":5,"role":36},"Miha Arnol, Professor, MD, PhD, FEBTM","STUDY_DIRECTOR",[38],{"name":32,"role":39,"phone":40,"phoneExt":25,"email":41},"CONTACT","+386 1 522 2751","tanja.belcic.mikic@kclj.si",[43],{"facility":5,"status":25,"city":44,"state":25,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Ljubljana","1000","Slovenia","SI",{"type":49,"coordinates":50},"Point",[51,52],14.50513,46.05108,{"lat":52,"lon":51},[55,58,59,62,64,66],{"name":35,"role":39,"phone":56,"phoneExt":25,"email":57},"+386 1 522 8977, +38615225214","miha.arnol@kclj.si",{"name":32,"role":33,"phone":25,"phoneExt":25,"email":25},{"name":60,"role":61,"phone":25,"phoneExt":25,"email":25},"Manca Oblak, MD, PhD","SUB_INVESTIGATOR",{"name":63,"role":61,"phone":25,"phoneExt":25,"email":25},"Bor Vratanar, PhD",{"name":65,"role":61,"phone":25,"phoneExt":25,"email":25},"Valentina Cernetic Korelec, MD",{"name":67,"role":61,"phone":25,"phoneExt":25,"email":25},"Gregor Mlinsek, MD, PhD",{"type":33,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Tanja Belčič Mikič","MD, PhD, FEBTM","100606700","potassium-rich-salt-substitutes-in-kidney-transplant-recipients-100606700",false,"NCT07178964","POTASSIUM-RICH SALT SUBSTITUTES IN KIDNEY TRANSPLANT RECIPIENTS","THE USE OF POTASSIUM-RICH SALT SUBSTITUTES IN BLOOD PRESSURE CONTROL OF KIDNEY TRANSPLANT RECIPIENTS","Inclusion Criteria:\n\n* patients with a transplanted kidney ≥ 3 months post kidney-transplant\n* a functioning transplanted kidney with estimated glomerular filtration rate (eGFR) according to CKD\u002FEPI equation of at least 25 ml\u002Fmin\n* Elevated blood pressure\u002Fhypertension at the time of examination at the Kidney Transplantation Center outpatient clinic, determined by standardized blood pressure measurement (RR ≥ 130\u002F80 mmHg)\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* eGFR according to CKD\u002FEPI equation below 25 ml\u002Fmin\n* serum potassium \\> 5 mmol\u002Fl\n* history of unexplained hyperkalemia\n* pregnancy or planning of pregnancy\n* inability to provide informed consent or to participate in the study (mental retardation, psychiatric illness in an uncontrolled phase)\n* multiple organ transplantation\n* Consuming most of daily meals outside the home environment","ALL","18 Years",{"count":81,"type":82},80,"ESTIMATED","INTERVENTIONAL",[85],"NA","Excessive sodium intake and inadequate potassium intake in the diet are known risk factors for the development of arterial hypertension and an increased risk of cardiovascular events. Data from randomized controlled trials show that the use of salt substitutes with reduced sodium and increased potassium content represent an effective way to reduce dietary sodium intake, blood pressure and the occurrence of cardiovascular events. Patients adhere well to the use of salt substitutes as they do not have to change their daily cooking and seasoning habits and the taste is comparable to that of regular salt. The World Health Organization (WHO) also suggests the use of salt substitutes as an acceptable strategy for reducing dietary salt intake and thus lowering blood pressure and the burden of cardiovascular disease. Recommendations for the use of salt substitutes are not uniform, primarily because of the potential risk of adverse events with increased potassium intake in some individuals, such as patients with advanced chronic kidney disease (CKD), patients receiving potassium-sparing diuretics, and patients receiving potassium supplements.\n\nNephrology guidelines rarely comment on the use of potassium-rich salt substitutes or discourage their use in patients with advanced stage 4 and 5 CKD, with the exception of Chinese guidelines, which mention the use of potassium-rich salt substitutes in CKD patients not on dialysis depending on serum potassium levels. CKD patients have largely been excluded from clinical trials of potassium-rich salt substitutes, so there is insufficient data on their safety and efficacy in CKD patients.\n\nIn this randomized controlled trial, we will investigate the effects of using potassium-enriched salt substitutes on blood pressure control and serum potassium levels in kidney transplant recipients. In the intervention group, patients will use potassium-enriched salt substitutes at home in a ratio of 75% sodium chloride and 25% potassium chloride instead of regular table salt (100% sodium chloride) for cooking and seasoning food. In the control group, patients will use regular salt at home for cooking and seasoning food. The intervention and control groups will each include 40 to 50 patients who will be monitored for 12 weeks. The study's main focus will be the change in serum potassium and blood pressure before and after the intervention.\n\nWe expect to confirm the positive effects of potassium-enriched salt substitutes on blood pressure in kidney transplant recipients without causing undesirable hyperkalemia.",[88,89],"Hypertension Arterial","Kidney Transplant","NOT_YET_RECRUITING","2025-09-10",{"date":93,"type":94},"2025-09-17","ACTUAL",{"date":96,"type":82},"2025-10-01",{"date":98,"type":82},"2026-09-30",{"name":5,"class":6},1]