Withings Heart Function Risk Notification Retrospective Study (HFRN)
2026年6月12日 更新者：Withings
Validation of the Withings Heart Function Risk Notification (HFRN): A Retrospective Study of Diagnostic Performance for Heart Failure Detection in US Consumer Smart-Scale Users
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) that analyzes longitudinal weight / BMI, body-water-percent variability, and activity (step) data collected passively by Withings connected smart scales and the Withings activity-tracking ecosystem.
The study estimates Sensitivity (Se) and Specificity (Sp) of HFRN against a US claims-based (HealthVerity) heart-failure reference standard, evaluated on a pre-specified holdout test set.
The findings support a 510(k) substantial-equivalence determination to the predicate Viz HCM (DEN230003) within the Cardiovascular machine learning-based notification software generic type (21 CFR 870.2380).
調査の概要
状態
まだ募集していません
条件
詳細な説明
This is a fully decentralized retrospective study.
Data were collected passively between 2020 and 2025 from consumer users of commercially available Withings devices in their home environments.
There are no physical study sites and no in-person visits.
研究の種類
観察的
入学 (推定)
9000
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Aline Criton, PhD
- 電話番号：+33 1.41.46.04.60
- メール：clinicaltrials-us@withings.com
研究場所
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Île-de-France Region
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Issy-les-Moulineaux、Île-de-France Region、フランス、92130
- Withings (Sponsor) - Decentralized Retrospective Study, No Physical Sites
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
サンプリング方法
非確率サンプル
調査対象母集団
Adult US consumer users (>= 45 years) of Withings connected smart scales (Body Cardio, Body Scan, Body Comp) with a source of step counts synced into the Withings ecosystem and successful linkage to US HealthVerity administrative claims, enabling heart-failure ground-truth ascertainment and covariate analyses.
The development dataset comprises 54,717 individuals (52,736 controls and 1,981 HF cases).
The pre-specified holdout test set comprises 9,093 individuals (8,548 controls and 545 HF cases), with case/control mix calibrated to the 2021 NHANES-estimated HF prevalence for US adults >= 45 years.
説明
Inclusion Criteria:
- Users of commercially purchased, consumer-grade Withings smart scales (e.g. Body Cardio [WBS04], Body Scan [WBS08], Body Comp [WBS12 / WBS12C]) used in a standard home environment
- A source of step counts synced into the Withings ecosystem (a Withings activity tracker, a smartphone, or a third-party activity tracker)
- US HealthVerity 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 (weight outside 20-400 kg, BMI outside 10-60 kg/m2, body-water percent outside 40-80%, daily steps outside 0-100,000, height outside 100-250 cm, or age outside 45-120 years)
- Users without an individual Withings account (shared accounts excluded to prevent data contamination)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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HF Cases
Withings smart-scale users with US HealthVerity claims linkage who meet the claims-based heart-failure case definition (>= 1 inpatient HF ICD-10 code, or >= 2 distinct outpatient-visit HF ICD-10 codes; per the first-match-wins claims algorithm).
Holdout test set: 545 HF cases.
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Software-only medical device (SaMD): an algorithm that analyzes quarterly-aggregated features computed from data passively captured by Withings connected smart scales and step counts synced into the Withings activity-tracking ecosystem.
When the predicted heart-failure risk probability exceeds a calibrated decision threshold, the device emits a notification directing the user to seek confirmatory clinical evaluation.
The notification is non-diagnostic.
Ground-truth heart-failure case / control status derived from US HealthVerity administrative claims by a deterministic, pre-specified rule set.
Per-user features (counts of HF ICD-10 codes split by inpatient vs. distinct outpatient visits, continuous-enrollment duration, supporting CPT and laboratory evidence) are passed through an ordered first-match-wins classifier.
Each user is additionally assigned a claims-operationalized ACC/AHA heart-failure stage (0 / A / B / C).
Adjudication is fully automated; no clinician adjudication is performed.
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Control
Withings smart-scale users with US HealthVerity claims linkage who meet the claims-based control definition (>= 2 years of continuous enrollment, no heart-failure ICD-10 evidence).
Holdout test set: 8,548 controls.
Case/control mix is calibrated to the 2021 NHANES-estimated heart-failure prevalence for US adults >= 45 years.
|
Software-only medical device (SaMD): an algorithm that analyzes quarterly-aggregated features computed from data passively captured by Withings connected smart scales and step counts synced into the Withings activity-tracking ecosystem.
When the predicted heart-failure risk probability exceeds a calibrated decision threshold, the device emits a notification directing the user to seek confirmatory clinical evaluation.
The notification is non-diagnostic.
Ground-truth heart-failure case / control status derived from US HealthVerity administrative claims by a deterministic, pre-specified rule set.
Per-user features (counts of HF ICD-10 codes split by inpatient vs. distinct outpatient visits, continuous-enrollment duration, supporting CPT and laboratory evidence) are passed through an ordered first-match-wins classifier.
Each user is additionally assigned a claims-operationalized ACC/AHA heart-failure stage (0 / A / B / C).
Adjudication is fully automated; no clinician adjudication is performed.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
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Sensitivity (Se) and its 95% CI of the HFRN algorithm for heart-failure detection, evaluated on the pre-specified holdout test set.
時間枠：13 weeks
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13 weeks
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Specificity (Sp) and its 95% CI of the HFRN algorithm for heart-failure detection, evaluated on the pre-specified holdout test set.
時間枠：13 weeks
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13 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Pierre Escourrou, MD, PhD、Centre Interdisciplinaire du Sommeil, Paris, France
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2026年9月1日
研究の完了 (推定)
2026年9月1日
試験登録日
最初に提出
2026年6月12日
QC基準を満たした最初の提出物
2026年6月12日
最初の投稿 (実際)
2026年6月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月17日
QC基準を満たした最後の更新が送信されました
2026年6月12日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
心不全の臨床試験
-
Novartis Pharmaceuticals完了EC-MPS による治療に関心があり、コア研究の 12 か月の治療期間を無事に完了した患者 (de novo Heart Recipients)