Heart FailureNCT07654491
Withings HFRN Retrospective Study
An observational study of Heart Failure, run by Withings at 1 site in France.
Trial 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) Read more about this study
- Who is it for?
- Ages 45 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Withings Heart Function Risk Notification (HFRN) and Claims-based heart-failure adjudication (reference standard)
- Type of treatment
- Medical device
- How many people
- 9,000 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2026to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult US consumer users (>= 45 years) of Withings connected smart scales
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Withings (Sponsor) - Decentralized Retrospective Study, No Physical Sites
Issy-les-Moulineaux, Île-de-France Region, 92130
About this study
Official title: 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)
Read the detailed description
This is a fully decentralized retrospective study.
- Conditions
- Heart Failure
- Being tested
- Withings Heart Function Risk Notification (HFRN), Claims-based heart-failure adjudication (reference standard)
- Keywords
- mhealth
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| HF Cases | Withings smart-scale users Receives: Device: Withings Heart Function Risk Notification (HFRN); Other: Claims-based heart-failure adjudication (reference standard) | |
| Control | Withings smart-scale users, control set Receives: Device: Withings Heart Function Risk Notification (HFRN); Other: Claims-based heart-failure adjudication (reference standard) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity (Se) of the HFRN algorithm
Measured: 13 weeks
Specificity (Sp) of the HFRN algorithm
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 9,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Withings
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierre Escourrou, MD, PhD, Principal investigator, Centre Interdisciplinaire du Sommeil, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654491
- Sponsor's protocol ID
- HFRN
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Withings Heart Function Risk Notification (HFRN)
- ClinicalTrials.gov ID
- NCT07654491
- Acronym / sponsor ID
- HFRN
- Conditions
- Heart Failure
- Keywords
- mhealth
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 9,000 participants (estimated)
- Lead sponsor
- WithingsIndustry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HF Cases | – | Device: Withings Heart Function Risk Notification (HFRN), Other: Claims-based heart-failure adjudication (reference standard)Withings smart-scale users |
| Control | – | Device: Withings Heart Function Risk Notification (HFRN), Other: Claims-based heart-failure adjudication (reference standard)Withings smart-scale users, control set |
Who may qualify
- Ages
- 45 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult US consumer users (>= 45 years) of Withings connected smart scales
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Withings Heart Function Risk Notification (HFRN)Software-only medical device (SaMD) | Device | Control, HF Cases |
| 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. | Other | Control, HF Cases |
Primary outcome
Sensitivity (Se) of the HFRN algorithm
Time frame: 13 weeks
Specificity (Sp) of the HFRN algorithm
Time frame: 13 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierre Escourrou, MD, PhD principal investigator
Centre Interdisciplinaire du Sommeil, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Withings at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aline Criton, PhD (+33 1.41.46.04.60, clinicaltrials-us@withings.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (Se) of the HFRN algorithm (time frame: 13 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026; AzTrials last refreshed its copy on 28 Oct 2026.