Withings HFRN Retrospective Study

NCT07654491 | Not Yet Recruiting FDA Device

• 1 other identifier: HFRN
• Study Type: observational
• Target: 9,000
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Heart Failure

Keywords

mhealth

Outcome Measures

Primary Outcomes (2)

• Sensitivity (Se) of the HFRN algorithm

  13 weeks

• Specificity (Sp) of the HFRN algorithm

  13 weeks

Study Arms (2)

HF Cases

Withings smart-scale users

Device: Withings Heart Function Risk Notification (HFRN); Other: Claims-based heart-failure adjudication (reference standard)

Control

Withings smart-scale users, control set

Device: Withings Heart Function Risk Notification (HFRN); Other: Claims-based heart-failure adjudication (reference standard)

Interventions

Withings Heart Function Risk Notification (HFRN) DEVICE

Software-only medical device (SaMD)

Control; HF Cases

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.

Control; HF Cases

Eligibility Criteria

• Age: 45 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Withings: lead

Study Sites (1)

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

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

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Reference Standards

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Weights and Measures; Investigative Techniques

Study Officials

• Pierre Escourrou, MD, PhD

  Centre Interdisciplinaire du Sommeil, Paris, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aline Criton, PhD

CONTACT

+33 1.41.46.04.60; clinicaltrials-us@withings.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)