Withings Heart Function Risk Notification (HFRN)Claims-based heart-failure adjudication (reference standard)
Withings Heart Function Risk Notification (HFRN): Software-only medical device (SaMD)
Claims-based heart-failure adjudication (reference standard): Ground-truth heart-failure case / control status derived from administrative claims by a deterministic, pre-specified rule set.
Study summary
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
Sex
ALL
Min age
45 Years
Max age
120 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* 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
* 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
Exclusion Criteria:
* 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)
Primary outcome measure(s)
Sensitivity (Se) of the HFRN algorithm — 13 weeks
Specificity (Sp) of the HFRN algorithm — 13 weeks
Trial sites (1)
Facility
City
Region
Status
Withings (Sponsor) - Decentralized Retrospective Study, No Physical Sites
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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