An observational study in Heart Failure, sponsored by Withings. Not yet recruiting at 1 site in France. Open to participants aged 45 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Withings · Observational
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)
This is a fully decentralized retrospective study.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 9,000 is above the median of 200 across 1,983 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Withings is the lead sponsor of 23 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult US consumer users (>= 45 years) of Withings connected smart scales
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Withings smart-scale users
Device: Withings Heart Function Risk Notification (HFRN) · Other: Claims-based heart-failure adjudication (reference standard)
Withings smart-scale users, control set
Device: Withings Heart Function Risk Notification (HFRN) · Other: Claims-based heart-failure adjudication (reference standard)
Software-only medical device (SaMD)
Ground-truth heart-failure case / control status derived from administrative claims by a deterministic, pre-specified rule set.
Sensitivity (Se) of the HFRN algorithm
Time frame: 13 weeks
Specificity (Sp) of the HFRN algorithm
Time frame: 13 weeks
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Sep 2026, 3 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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