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
Qualifiers
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 design
Treatments tested in this trial
- Withings Heart Function Risk Notification (HFRN)
- Claims-based heart-failure adjudication (reference standard)
Treatment groups
9,000 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov