Withings HFRN Retrospective Study

Validation of the Withings Heart Function Risk Notification (HFRN)

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07654491

Enrollment

9000

Registered

2026-06-17

Start date

2026-06-01

Completion date

2026-09-01

Last updated

2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

mhealth

Brief 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)

Detailed description

This is a fully decentralized retrospective study.

Interventions

DEVICEWithings Heart Function Risk Notification (HFRN)

Software-only medical device (SaMD)

OTHERClaims-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 design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to 120 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Sensitivity (Se) of the HFRN algorithm	13 weeks
Specificity (Sp) of the HFRN algorithm	13 weeks

Countries

France

Contacts

CONTACTAline Criton, PhD

clinicaltrials-us@withings.com+33 1.41.46.04.60

PRINCIPAL_INVESTIGATORPierre Escourrou, MD, PhD

Centre Interdisciplinaire du Sommeil, Paris, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026