[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641560":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":54,"collaborators":10,"id":56,"slug":10,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":10,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":10,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":75,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Withings","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"HF Cases",null,"Withings smart-scale users",[13,14],"Device: Withings Heart Function Risk Notification (HFRN)","Other: Claims-based heart-failure adjudication (reference standard)",{"label":16,"type":10,"description":17,"interventionNames":18},"Control","Withings smart-scale users, control set",[13,14],[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DEVICE","Withings Heart Function Risk Notification (HFRN)","Software-only medical device (SaMD)",[16,9],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"OTHER","Claims-based heart-failure adjudication (reference standard)","Ground-truth heart-failure case \u002F control status derived from administrative claims by a deterministic, pre-specified rule set.",[16,9],[31],{"name":32,"affiliation":33,"role":34},"Pierre Escourrou, MD, PhD","Centre Interdisciplinaire du Sommeil, Paris, France","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":10,"email":40},"Aline Criton, PhD","CONTACT","+33 1.41.46.04.60","clinicaltrials-us@withings.com",[42],{"facility":43,"status":10,"city":44,"state":45,"zip":46,"country":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":10},"Withings (Sponsor) - Decentralized Retrospective Study, No Physical Sites","Issy-les-Moulineaux","Île-de-France Region","92130","France",{"type":49,"coordinates":50},"Point",[51,52],2.27718,48.82104,{"lat":52,"lon":51},{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100641560",false,"NCT07654491","Withings HFRN Retrospective Study","Validation of the Withings Heart Function Risk Notification (HFRN)","Inclusion Criteria:\n\n* Users of commercially purchased, consumer-grade Withings smart scales\n* A source of step counts synced into the Withings ecosystem (a Withings activity tracker, a smartphone, or a third-party activity tracker)\n* Claims linkage available, enabling heart-failure ground-truth ascertainment\n* Age \\>= 45 years\n* At least one 13-week quarter in which at least one of the three quarterly features (mean BMI, standard deviation of body-water percent, 90th-percentile daily steps) can be computed\n\nExclusion Criteria:\n\n* Users for whom heart-failure status cannot be determined from claims (unknown label; e.g. controls with \\\u003C 2 years of continuous enrollment)\n* Users with no usable measurement after per-reading plausibility screening\n* Users without an individual Withings account (shared accounts excluded to prevent data contamination)",true,"ALL","45 Years","120 Years",{"count":67,"type":68},9000,"ESTIMATED","OBSERVATIONAL","This is a fully decentralized retrospective, non-interventional study evaluating the diagnostic performance of the Withings Heart Function Risk Notification (HFRN), a software-only medical device (SaMD)",[72],"Heart Failure",[74],"mhealth","NOT_YET_RECRUITING","2026-06-29",{"date":78,"type":79},"2026-07-01","ACTUAL",{"date":81,"type":68},"2026-06",{"date":83,"type":68},"2026-09",{"name":5,"class":6},1]