NCT07654491Not yet recruiting
Withings HFRN Retrospective Study
Validation of the Withings Heart Function Risk Notification (HFRN)
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 9000 (estimated)
- First submitted
- 12 Jun 2026
- Start date
- Jun 2026
- Primary completion date
- Sept 2026
- Lead sponsor
- Withings
- Diseases
- Heart failure
- NCT number
- NCT07654491
What you commit to
- Study type: Observational
- Planned participants: 9000
- From Jun 2026 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Users for whom heart-failure status cannot be determined from claims (unknown label; e.g. controls with \< 2 years of continuous enrollment)
Other
- Users with no usable measurement after per-reading plausibility screening
- Users without an individual Withings account (shared accounts excluded to prevent data contamination)
Who the study is looking for
- 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
Age in the registry: 45 years to 120 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Withings (Sponsor) - Decentralized Retrospective Study, No Physical Sites Coordinator of this site? Confirm its status | Issy-les-Moulineaux | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.