[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609089":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":30,"responsibleParty":50,"collaborators":10,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":10,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":10,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"AccurKardia, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 2A - Outpatient Diagnostic Accuracy",null,"Participants with chronic kidney disease (CKD) stages III-IV who are scheduled for a routine outpatient potassium blood test. At the same clinic visit, participants will have ECGs recorded using three devices (12-lead ECG, Apple Watch, and HeartBeam) for analysis by the AK+ Guard™ software. Researchers will compare the software's results with the laboratory potassium values to estimate sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).",[13],"Device: AK+ Guard™ ECG Application",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm 2B - Remote Patient Monitoring","A subset of participants from Arm 2A (Outpatient Diagnostic Accuracy) who agree to continue with at-home monitoring for up to four weeks. These participants will use an Apple Watch and study application to record daily ECGs. They will complete short weekly surveys about ease of use, anxiety, and safety perceptions, and return for a confirmatory laboratory test if the AK+ Guard™ software signals possible high potassium. Researchers will assess daily compliance, usability, and overall system reliability in a real-world setting.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DEVICE","AK+ Guard™ ECG Application","An investigational Software as a Medical Device (SaMD) that analyzes Lead I electrocardiogram (ECG) data using artificial intelligence to detect moderate to severe hyperkalemia (serum potassium ≥ 6.5 mmol\u002FL). ECG inputs may be obtained from standard 12-lead ECGs, clinical-grade ECG devices with Lead I capability, or consumer wearable devices (e.g., Apple Watch, HeartBeam).",[9,15],[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Moin Hussaini","CONTACT","718-708-3522","mhussaini@accurkardia.com",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Central Jersey Kidney Care - Hypertension & Nephrology Associates","RECRUITING","Eatontown","New Jersey","07724","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-74.05097,40.29622,{"lat":43,"lon":42},[46],{"name":47,"role":27,"phone":48,"phoneExt":10,"email":49},"Danit Silberman","732-460-1200","danitsilb@gmail.comEatontown",{"type":51,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","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":62,"type":63},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.",[67,68],"Hyperkalemia","Chronic Kidney Disease (Stage 3-4)",[70,71,72,73,74],"hyperkalemia","ambulatory CKD","CKD","chronic kidney disease","ECG","2025-10-14",{"date":77,"type":78},"2025-10-16","ACTUAL",{"date":75,"type":78},{"date":81,"type":63},"2025-11-28",{"name":5,"class":6},1]