Withings HFRN Retrospective Study (HFRN)

June 29, 2026 updated by: Withings

Validation of the Withings Heart Function Risk Notification (HFRN)

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a fully decentralized retrospective study.

Study Type

Observational

Enrollment (Estimated)

9000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adult US consumer users (>= 45 years) of Withings connected smart scales

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HF Cases
Withings smart-scale users
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.
Control
Withings smart-scale users, control set
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity (Se) of the HFRN algorithm
Time Frame: 13 weeks
13 weeks
Specificity (Sp) of the HFRN algorithm
Time Frame: 13 weeks
13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Withings

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

June 12, 2026

First Submitted That Met QC Criteria

June 12, 2026

First Posted (Actual)

June 17, 2026

Study Record Updates

Last Update Posted (Actual)

July 1, 2026

Last Update Submitted That Met QC Criteria

June 29, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFRN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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