Checking how well a Withings device flags heart failure risk
Evaluates a software tool that flags heart failure risk in older adults.
Plain-language title generated from the registry record
Registry title: Withings HFRN Retrospective Study
Key facts
- Where
- Issy-les-Moulineaux, FranceSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 45 and 120 years old?
Source: NCT07654491, who can take part
Where in France
- Withings (Sponsor) - Decentralized Retrospective Study, No Physical SitesIssy-les-Moulineaux, FranceNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Withings
- Trial code
- NCT07654491
- Record updated
- 1 July 2026
- Original description
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)Read full original descriptionShow less
Validation of the Withings Heart Function Risk Notification (HFRN)
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)
Inclusion: 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: 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).