Withings HFRN Retrospective Study | NCT07654491

Studies
Withings HFRN Retrospective Study

NCT07654491

Sponsor

Withings

Status

Not yet recruiting

Last Update Posted

Jul 1, 2026Actual

Enrollment

9,000Estimated

Phase

Not provided

Conditions

Heart Failure

Interventions

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

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2026Estimated

Primary Completion Date

Sep 2026Estimated

Completion Date

Sep 2026Estimated

First Submitted Date

Jun 12, 2026

First Submission Date that Met QC Criteria

Jun 12, 2026

First Posted Date

Jun 17, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2026

Last Update Posted Date

Jul 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

This is a fully decentralized retrospective study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Withings Heart Function Risk Notification (HFRN)	Device	Software-only medical device (SaMD)	Control HF Cases

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Aline Criton, PhD	Contact	+33 1.41.46.04.60		clinicaltrials-us@withings.com

Overall Officials

Name	Affiliation	Role
Pierre Escourrou, MD, PhD	Centre Interdisciplinaire du Sommeil, Paris, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Withings (Sponsor) - Decentralized Retrospective Study, No Physical Sites		Issy-les-Moulineaux	Île-de-France Region	92130	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012015	Reference Standards

Ancestor Terms

ID	Term
D014894	Weights and Measures
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided