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Not yet recruiting NCT07654491

Withings HFRN Retrospective Study

— Observational Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Withings Heart Function Risk Notification (HFRN), Claims-based heart-failure adjudication (reference standard).
Who it may be relevant to
Registry conditions: Heart Failure. Basic parameters: 45 years — 120 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Validation of the Withings Heart Function Risk Notification (HFRN)

Overview

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

  • Device Withings Heart Function Risk Notification (HFRN)
    Software-only medical device (SaMD)
  • Other 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.

Primary outcome measures

  • Sensitivity (Se) of the HFRN algorithm [Time frame: 13 weeks]
  • Specificity (Sp) of the HFRN algorithm [Time frame: 13 weeks]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Withings (Sponsor) - Decentralized Retrospective Study, No Physical Sites — Issy-les-Moulineaux

Identifiers

NCT: NCT07654491 · HFRN

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗