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Withings Heart Function Risk Notification Retrospective Study (HFRN)

12. juni 2026 oppdatert av: Withings

Validation of the Withings Heart Function Risk Notification (HFRN): A Retrospective Study of Diagnostic Performance for Heart Failure Detection in US Consumer Smart-Scale Users

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) that analyzes longitudinal weight / BMI, body-water-percent variability, and activity (step) data collected passively by Withings connected smart scales and the Withings activity-tracking ecosystem. The study estimates Sensitivity (Se) and Specificity (Sp) of HFRN against a US claims-based (HealthVerity) heart-failure reference standard, evaluated on a pre-specified holdout test set. The findings support a 510(k) substantial-equivalence determination to the predicate Viz HCM (DEN230003) within the Cardiovascular machine learning-based notification software generic type (21 CFR 870.2380).

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a fully decentralized retrospective study. Data were collected passively between 2020 and 2025 from consumer users of commercially available Withings devices in their home environments. There are no physical study sites and no in-person visits.

Studietype

Observasjonsmessig

Registrering (Antatt)

9000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Frankrike
    • Île-de-France Region
      • Issy-les-Moulineaux, Île-de-France Region, Frankrike, 92130
        • Withings (Sponsor) - Decentralized Retrospective Study, No Physical Sites

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Adult US consumer users (>= 45 years) of Withings connected smart scales (Body Cardio, Body Scan, Body Comp) with a source of step counts synced into the Withings ecosystem and successful linkage to US HealthVerity administrative claims, enabling heart-failure ground-truth ascertainment and covariate analyses. The development dataset comprises 54,717 individuals (52,736 controls and 1,981 HF cases). The pre-specified holdout test set comprises 9,093 individuals (8,548 controls and 545 HF cases), with case/control mix calibrated to the 2021 NHANES-estimated HF prevalence for US adults >= 45 years.

Beskrivelse

Inclusion Criteria:

  • Users of commercially purchased, consumer-grade Withings smart scales (e.g. Body Cardio [WBS04], Body Scan [WBS08], Body Comp [WBS12 / WBS12C]) used in a standard home environment
  • A source of step counts synced into the Withings ecosystem (a Withings activity tracker, a smartphone, or a third-party activity tracker)
  • US HealthVerity 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 (weight outside 20-400 kg, BMI outside 10-60 kg/m2, body-water percent outside 40-80%, daily steps outside 0-100,000, height outside 100-250 cm, or age outside 45-120 years)
  • Users without an individual Withings account (shared accounts excluded to prevent data contamination)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
HF Cases
Withings smart-scale users with US HealthVerity claims linkage who meet the claims-based heart-failure case definition (>= 1 inpatient HF ICD-10 code, or >= 2 distinct outpatient-visit HF ICD-10 codes; per the first-match-wins claims algorithm). Holdout test set: 545 HF cases.
Enhet: Withings Heart Function Risk Notification (HFRN)
Software-only medical device (SaMD): an algorithm that analyzes quarterly-aggregated features computed from data passively captured by Withings connected smart scales and step counts synced into the Withings activity-tracking ecosystem. When the predicted heart-failure risk probability exceeds a calibrated decision threshold, the device emits a notification directing the user to seek confirmatory clinical evaluation. The notification is non-diagnostic.
Annen: Claims-based heart-failure adjudication (reference standard)
Ground-truth heart-failure case / control status derived from US HealthVerity administrative claims by a deterministic, pre-specified rule set. Per-user features (counts of HF ICD-10 codes split by inpatient vs. distinct outpatient visits, continuous-enrollment duration, supporting CPT and laboratory evidence) are passed through an ordered first-match-wins classifier. Each user is additionally assigned a claims-operationalized ACC/AHA heart-failure stage (0 / A / B / C). Adjudication is fully automated; no clinician adjudication is performed.
Control
Withings smart-scale users with US HealthVerity claims linkage who meet the claims-based control definition (>= 2 years of continuous enrollment, no heart-failure ICD-10 evidence). Holdout test set: 8,548 controls. Case/control mix is calibrated to the 2021 NHANES-estimated heart-failure prevalence for US adults >= 45 years.
Enhet: Withings Heart Function Risk Notification (HFRN)
Software-only medical device (SaMD): an algorithm that analyzes quarterly-aggregated features computed from data passively captured by Withings connected smart scales and step counts synced into the Withings activity-tracking ecosystem. When the predicted heart-failure risk probability exceeds a calibrated decision threshold, the device emits a notification directing the user to seek confirmatory clinical evaluation. The notification is non-diagnostic.
Annen: Claims-based heart-failure adjudication (reference standard)
Ground-truth heart-failure case / control status derived from US HealthVerity administrative claims by a deterministic, pre-specified rule set. Per-user features (counts of HF ICD-10 codes split by inpatient vs. distinct outpatient visits, continuous-enrollment duration, supporting CPT and laboratory evidence) are passed through an ordered first-match-wins classifier. Each user is additionally assigned a claims-operationalized ACC/AHA heart-failure stage (0 / A / B / C). Adjudication is fully automated; no clinician adjudication is performed.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Sensitivity (Se) and its 95% CI of the HFRN algorithm for heart-failure detection, evaluated on the pre-specified holdout test set.
Tidsramme: 13 weeks
13 weeks
Specificity (Sp) and its 95% CI of the HFRN algorithm for heart-failure detection, evaluated on the pre-specified holdout test set.
Tidsramme: 13 weeks
13 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Withings

Etterforskere

  • Hovedetterforsker: Pierre Escourrou, MD, PhD, Centre Interdisciplinaire du Sommeil, Paris, France

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. september 2026

Studiet fullført (Antatt)

1. september 2026

Datoer for studieregistrering

Først innsendt

12. juni 2026

Først innsendt som oppfylte QC-kriteriene

12. juni 2026

Først lagt ut (Faktiske)

17. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HFRN

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

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