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Withings Heart Function Risk Notification Retrospective Study (HFRN)

12. juni 2026 opdateret af: 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).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

9000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / 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.
Enhed: 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.
Andet: 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.
Enhed: 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.
Andet: 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.

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Withings

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. september 2026

Studieafslutning (Anslået)

1. september 2026

Datoer for studieregistrering

Først indsendt

12. juni 2026

Først indsendt, der opfyldte QC-kriterier

12. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HFRN

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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