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Clinical Trials in France / NCT07654491
Starting soon Observational

Withings HFRN Retrospective Study

NCT07654491 · tracked via the Priya Life Science France tracker
Sponsor
Phase
Observational
Started
2026-06
Last updated
2026-07-01

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

Withings Heart Function Risk Notification (HFRN)Claims-based heart-failure adjudication (reference standard)

Withings Heart Function Risk Notification (HFRN): Software-only medical device (SaMD)

Claims-based heart-failure adjudication (reference standard): Ground-truth heart-failure case / control status derived from administrative claims by a deterministic, pre-specified rule set.

Study summary

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

Sex
ALL
Min age
45 Years
Max age
120 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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 Criteria: * 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)

Primary outcome measure(s)

Trial sites (1)

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

More Withings trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07654491 on ClinicalTrials.gov ↗ ← All trials in France