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NCT Number: NCT07654491

Withings HFRN Retrospective Study

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)

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

45 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Withings (Sponsor) - Decentralized Retrospective Study, No Physical Sites

Issy-les-Moulineaux, Île-de-France Region, 92130, France

About this study

This is a fully decentralized retrospective study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Withings Heart Function Risk Notification (HFRN)

Device

Software-only medical device (SaMD)

Claims-based heart-failure adjudication (reference standard)

Other

Ground-truth heart-failure case / control status derived from administrative claims by a deterministic, pre-specified rule set.

Primary outcomes

  1. Sensitivity (Se) of the HFRN algorithm

    Time frame: 13 weeks

  2. Specificity (Sp) of the HFRN algorithm

    Time frame: 13 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Aline Criton, PhD

CONTACT

[email protected]

+33 1.41.46.04.60

Sponsors and collaborators

Lead sponsor

Withings

Industry

Registry information

Official study title

Validation of the Withings Heart Function Risk Notification (HFRN)

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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