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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 45 or older who use a Withings smart scale, have step counts synced to Withings, and have insurance claims data.
- Age
- 45 years or older (up to 120 years)
- Sex
- All sexes can join.
Main reasons for not taking part
- Heart-failure status cannot be determined from claims (for example, controls with less than 2 years of continuous enrollment)
- No usable measurements after the reading plausibility screening
- No individual Withings account (shared accounts are excluded)
Read by machine on 9 November 2026.
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).