[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hospital de Messejana Dr. Carlos Alberto Studart Gomes\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":49},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100633221","phase-4-spironolactone-alternate-dosing-vs-finerenone-in-elevated-potassium---k-safety-study-100633221",false,"NCT07523867","Spironolactone Alternate Dosing vs Finerenone in Elevated Potassium - K Safety Study","Safety of Finerenone Versus Alternate-Day Spironolactone in Patients With Heart Failure and Diabetic Kidney Disease at High Risk for Hyperkalemia: The SAFE-K Randomized Trial","SAFE-K","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of heart failure, regardless of left ventricular ejection fraction\n* Diagnosis of type 2 diabetes mellitus\n* Diabetic kidney disease, defined by the presence of albuminuria (urinary albumin-to-creatinine ratio ≥ 30 mg\u002Fg)\n* Estimated glomerular filtration rate (eGFR) ≥ 25 mL\u002Fmin\u002F1.73 m²\n* Serum potassium between 5.0 and 5.5 mEq\u002FL at screening\n* Receiving or eligible to receive standard of care therapy for heart failure\n* Ability to provide written informed consent\n* Ability to comply with study procedures and follow-up visits\n\nExclusion Criteria:\n\n* Serum potassium \\> 5.5 mEq\u002FL at screening\n* Acute kidney injury at the time of enrollment\n* Symptomatic hypotension or systolic blood pressure \\\u003C 90 mmHg\n* Clinically significant arrhythmias requiring immediate intervention\n* Known hypersensitivity or contraindication to finerenone or spironolactone\n* Use of potassium-sparing diuretics other than the study drugs\n* Pregnancy or breastfeeding\n* Participation in another interventional clinical trial\n* Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study procedures","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This study evaluates the safety of finerenone compared with alternate-day spironolactone in patients with heart failure and diabetic kidney disease at increased risk of hyperkalemia.\n\nPatients with chronic kidney disease and heart failure often benefit from mineralocorticoid receptor antagonists, but their use is frequently limited by elevated potassium levels. Finerenone has been associated with a lower risk of hyperkalemia in clinical trials, but direct comparisons with spironolactone in high-risk patients are limited.\n\nIn this randomized study, eligible participants will be assigned to receive either finerenone once daily or spironolactone on alternate days, in addition to standard therapy. Patients will be closely monitored during hospitalization and followed for 4 weeks.\n\nThe primary outcome is clinically relevant hyperkalemia, defined by elevated potassium levels or the need to adjust or discontinue treatment due to hyperkalemia. Secondary outcomes include changes in potassium levels, kidney function, and clinical events.\n\nThis study aims to provide practical evidence to guide the safe use of mineralocorticoid receptor antagonists in patients at high risk for hyperkalemia.",[27,28,29],"Heart Failure","Diabetic Kidney Disease","Hyperkalemia",[31,32,33,34,29,35,36],"Finerenone","Spironolactone","Heart Failure Treatment","Chronic Kidney Disease","Mineralocorticoid Receptor Antagonist","Cardiorenal Syndrome","NOT_YET_RECRUITING","2026-05-09",{"date":40,"type":41},"2026-05-13","ACTUAL",{"date":43,"type":21},"2026-04",{"date":45,"type":21},"2026-11",{"name":47,"class":48},"Hospital de Messejana Dr. Carlos Alberto Studart Gomes","OTHER_GOV",""]