Withings HFRN Retrospective Study
ConditionHeart Failure
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45-120
SponsorWithings
About this trial
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)
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Users of commercially purchased, consumer-grade Withings smart scales
A source of step counts synced into the Withings ecosystem (a Withings activity tracker, a smartphone, or a third-party activity tracker)
Claims linkage available, enabling heart-failure ground-truth ascertainment
Age >= 45 years
Disqualifiers
Users for whom heart-failure status cannot be determined from claims (unknown label; e.g. controls with < 2 years of continuous enrollment)
Users with no usable measurement after per-reading plausibility screening
Users without an individual Withings account (shared accounts excluded to prevent data contamination)
Trial population
Adult US consumer users (\>= 45 years) of Withings connected smart scales
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Withings Heart Function Risk Notification (HFRN)
DeviceSoftware-only medical device (SaMD)
Claims-based heart-failure adjudication (reference standard)
Other interventionGround-truth heart-failure case / control status derived from administrative claims by a deterministic, pre-specified rule set.
Treatment groups
9,000 Participants
are divided into 2 treatment groupsGroup A: HF Cases2 interventions
Group B: Control2 interventions
Trial outcomes
Primary outcomes
1
Sensitivity (Se) of the HFRN algorithm
Time frame
13 weeks2
Specificity (Sp) of the HFRN algorithm
Time frame
13 weeks Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: