[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"AccurKardia, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":43},{"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":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100609089","ak-guard-pilot-study-in-chronic-kidney-disease-outpatient-diagnostic-accuracy-and-remote-monitoring-100609089",false,"NCT07210021","AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring","Diagnostic Accuracy, Usability, Patient Compliance, and System Reliability of the AK+ Guard™ ECG Application for Hyperkalemia Prediction in Ambulatory Chronic Kidney Disease Patients (Outpatient and Remote Monitoring Arms)","Inclusion Criteria:\n\n(Arm 2A - Outpatient Diagnostic Accuracy)\n\n* Age 22 years or older\n* CKD stages III-IV managed at Central Jersey Kidney Care outpatient clinic\n* Scheduled outpatient serum potassium laboratory test\n* On RAASi therapy or documented hyperkalemia (K+ ≥ 5.5 mmol\u002FL) within the past 12 months\n* Able to provide written informed consent\n\n(Arm 2B - Remote Patient Monitoring)\n\n* Completion of Arm 2A visit\n* Owns an iPhone compatible with the study application\n\nExclusion Criteria (Both arms):\n\n* Age 21 years or younger\n* Pacemaker or implantable cardioverter defibrillator\n* Pre existing Left Bundle Branch Block (LBBB), Right Bundle Branch Block (RBBB), Intraventricular Conduction Delay (IVCD), or clinically significant hypocalcemia\n* Potassium lowering treatment administered before Lead I ECG acquisition\n* Trauma, acute events, or active interventions altering potassium homeostasis\n* Physical limitation precluding ECG acquisition","ALL","22 Years",{"count":19,"type":20},50,"ESTIMATED","OBSERVATIONAL","The goal of this observational pilot study is to evaluate the investigational AK+ Guard™ software as a medical device (SaMD) for detection of moderate to severe hyperkalemia (serum potassium (K+) ≥ 6.5 mmol\u002FL) in adults with chronic kidney disease (CKD).\n\nStudy objectives are:\n\n* Arm 2A (Outpatient Diagnostic Accuracy): To generate a preliminary, real-world signal of the diagnostic performance of AK+ Guard™ when used in an ambulatory CKD cohort for identifying clinically significant hyperkalemia episodes (serum K+ ≥ 6.5 mmol\u002FL) at the time of an outpatient laboratory draw.\n* Arm 2B (Remote Patient Monitoring): To assess participant compliance, usability, and end-to-end system reliability of AK+ Guard™ when deployed for daily remote monitoring of CKD patients outside the clinical environment for up to four weeks.",[24,25],"Hyperkalemia","Chronic Kidney Disease (Stage 3-4)",[27,28,29,30,31],"hyperkalemia","ambulatory CKD","CKD","chronic kidney disease","ECG","RECRUITING","2025-10-14",{"date":35,"type":36},"2025-10-16","ACTUAL",{"date":33,"type":36},{"date":39,"type":20},"2025-11-28",{"name":41,"class":42},"AccurKardia, Inc.","INDUSTRY",""]