Congestion assessment using a self-supervised contrastive learning-derived risk index in patients with congestive heart failure (CONAN): protocol and design of a prospective cohort study

European Heart Journal - Digital Health, vol. 6, pp. 1076–1083

Abstract

Aims: Recurrent congestive episodes are a primary cause of hospitalizations in patients with heart failure. Hitherto, outpatient management adopts a reactive approach, assessing patients clinically through frequent follow-up visits to detect congestion early. This study aims to assess the capabilities of a self-supervised contrastive learning-derived risk index to detect episodes of acute decompensated heart failure (ADHF) in patients using continuously recorded wearable time-series data. Methods and results: This is the protocol for a single-arm, prospective cohort pilot study that will include 290 patients with ADHF. Acute decompensated heart failure is diagnosed by clinical signs and symptoms, as well as additional diagnostics (e.g. NT-proBNP). Patients will receive standard-of-care treatment, supplemented by continuous wearable-based monitoring of vital signs and physical activity, and are followed for 90 days. During follow-up, study visits will be conducted and presentations without clinical ADHF will be referred to as 'regular' and data from these episodes will be presented to a deep neural network that is trained by a self-supervised contrastive learning objective to extract features from the time-series that are typical in regular periods. The model is used to calculate a risk index measuring the dissimilarity of observed features from those of regular periods. The primary outcome of this study will be the risk index's accuracy in detecting episodes with ADHF. As secondary outcome data integrity and the score in the validated questionnaire System Usability Scale will be evaluated. Conclusion: Demonstrating reliable congestion detection through continuous monitoring with a wearable and self-supervised contrastive learning could assist in pre-emptive heart failure management in clinical care. Clinical trial registration: The study was registered in the German clinical trials register (DRKS00034502).

Authors 13

1. Bojan Hartmann Aachen Department of Cardiology, Angiology and Intensive Care Medicine Medical Faculty

   RWTH Aachen University

   Affiliation as printed

   Department of Cardiology, Angiology and Intensive Care Medicine, Medical Faculty, RWTH Aachen University , Pauwelsstraße 30, Aachen 52074 ,

2. Niels‐Ulrik Korbinian Hartmann Aachen Department of Cardiology, Angiology and Intensive Care Medicine Medical Faculty

   RWTH Aachen University

   Affiliation as printed

   Department of Cardiology, Angiology and Intensive Care Medicine, Medical Faculty, RWTH Aachen University , Pauwelsstraße 30, Aachen 52074 ,

3. Julia Brandts Aachen Department of Cardiology, Angiology and Intensive Care Medicine Medical Faculty

   RWTH Aachen University

   Affiliation as printed

   Department of Cardiology, Angiology and Intensive Care Medicine, Medical Faculty, RWTH Aachen University , Pauwelsstraße 30, Aachen 52074 ,

4. Marlo Verket Aachen Department of Cardiology, Angiology and Intensive Care Medicine Medical Faculty

   RWTH Aachen University

   Affiliation as printed

   Department of Cardiology, Angiology and Intensive Care Medicine, Medical Faculty, RWTH Aachen University , Pauwelsstraße 30, Aachen 52074 ,

5. Nikolaus Marx Aachen Department of Cardiology, Angiology and Intensive Care Medicine Medical Faculty

   RWTH Aachen University

   Affiliation as printed

   Department of Cardiology, Angiology and Intensive Care Medicine, Medical Faculty, RWTH Aachen University , Pauwelsstraße 30, Aachen 52074 ,

6. Niveditha Dinesh Aachen Department of Cardiology, Angiology and Intensive Care Medicine Medical Faculty

   RWTH Aachen University

   Affiliation as printed

   Department of Cardiology, Angiology and Intensive Care Medicine, Medical Faculty, RWTH Aachen University , Pauwelsstraße 30, Aachen 52074 ,

7. Lisa Schuetze Aachen Department of Cardiology, Angiology and Intensive Care Medicine Medical Faculty

   RWTH Aachen University

   Affiliation as printed

   Department of Cardiology, Angiology and Intensive Care Medicine, Medical Faculty, RWTH Aachen University , Pauwelsstraße 30, Aachen 52074 ,

8. Dirk Müller‐Wieland Aachen Department of Cardiology, Angiology and Intensive Care Medicine Medical Faculty

   RWTH Aachen University

   Affiliation as printed

   Department of Cardiology, Angiology and Intensive Care Medicine, Medical Faculty, RWTH Aachen University , Pauwelsstraße 30, Aachen 52074 ,

9. Markus Kollmann

   Heinrich Heine University Düsseldorf

   Affiliation as printed

   Department of Biology, Heinrich Heine University Düsseldorf , Düsseldorf 40225 ,

10. Martin Berger Aachen Department of Cardiology, Angiology and Intensive Care Medicine Medical Faculty

    RWTH Aachen University

    Affiliation as printed

    Department of Cardiology, Angiology and Intensive Care Medicine, Medical Faculty, RWTH Aachen University , Pauwelsstraße 30, Aachen 52074 ,

11. Félix Michels

    Heinrich Heine University Düsseldorf

    Affiliation as printed

    Department of Biology, Heinrich Heine University Düsseldorf , Düsseldorf 40225 ,

12. Guido Kobbe

    Düsseldorf University Hospital · Heinrich Heine University Düsseldorf

    Affiliation as printed

    Department of Haematology, Oncology, and Clinical Immunology, Medical Faculty, University Hospital Düsseldorf, Heinrich Heine University Düsseldorf , Düsseldorf 40225 ,

13. Malte Jacobsen corresponding Aachen Department of Cardiology, Angiology and Intensive Care Medicine Medical Faculty

    RWTH Aachen University

    Affiliation as printed

    Department of Cardiology, Angiology and Intensive Care Medicine, Medical Faculty, RWTH Aachen University , Pauwelsstraße 30, Aachen 52074 ,