Withings HFRN Retrospective Study

Starting soon

Conditions studied: Heart Failure

In brief

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)

Key facts

Study ID

NCT07654491

Run by

Withings

People needed

9000

Starts

2026-06-01

Expected to finish

2026-09-01

Last updated by the study team

2026-07-01

Who can join

Age: 45 and older, up to 120. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Withings (Sponsor) - Decentralized Retrospective Study, No Physical Sites — Issy-les-Moulineaux, Île-de-France Region, France

Full record on ClinicalTrials.gov

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