Edge AI-deployed DIGItal Twins for PREDICTing Disease Progression and Need for Early Intervention in Infectious and Cardiovascular Diseases Beyond COVID-19 - Evaluation of Physiological Sensors

Fecha de inicio: 25 de mayo de 2023

Inclusion Criteria: * Presence of heart failure, defined as: symptoms and signs of heart failure, elevated baseline NT-proBNP levels (\>125pg/ml in sinus rhythm, \>365 pg/ml in atrial fibrillation) without severe kidney disease (defined as eGFR(MDRD)\<30 ml/min/1.73m²), and structural and/or functional abnormalities (according to 2021 ESC Heart Failure Guidelines) * At least 2 days of further treatment on a DHZC intensive care unit (H3i, IPS1, IPS2) or intermediate care unit (H3 - heart failure unit) expected at enrolment. * Age of subject is ≥ 18years. * Subject is female, male, divers. * Signed written informed consent. * For female subject or divers subject: 1. Negative highly sensitive urine or serum pregnancy test before inclusion, and 2. Practicing a highly effective birth control method (failure rate of less than 1%): 1. combined (estrogen and progestogen containing) hormonal 2. contraception associated with inhibition of ovulation (oral/intravaginal/ transdermal), or 3. progestogen-only hormonal contraception associated with inhibition of ovulation (oral/injectable/implantable), or 4. intrauterine device (IUD), or 5. intrauterine hormone-releasing system ( IUS), or 6. bilateral tubal occlusion, or 7. vasectomised partner, or 8. heterosexual abstinence. Exclusion Criteria: * Subject is breastfeeding. * Subject suffers from an addiction or from a disease that prevents the subject from recognizing nature, scope, and consequences of the study. * Subject is treated with immunosuppressive drugs at enrolment. * Subject requires mechanical circulatory support at enrolment (IABP, veno-arterial ECMO, Impella, VAD, TAH). * Subject requires extracorporeal lung support at enrolment (veno-venous ECMO, interventional lung assist). * Subject requires invasive ventilation at enrolment. * Subject requires renal replacement therapy. * Subjects with an active stimulation device (implanted or not) (e.g. pacemaker, nerve stimulator). * Subject has a known colonisation or infection with multi-drug-resistant pathogens. * Subject suffers from a skin disease at all possible placement sites for the DIGIPREDICT Physiopatch. Subject has damaged skin at all fingertips. * Subject has highly sensitive skin to (medical) adhesives. * Subject shows an inability to comply with all of the study procedures and follow-up visits. * Subjects who are unwilling to consent to saving and propagation of pseudonymised medical data for study reasons. * Subject is legally detained in an official institution. * Subject is dependent on the sponsor, the investigator or the study sites. * Subject participates in another clinical investigation according to MPDG/MDR, or in a study according to AMG/CTR that investigates immunosuppressive drugs at the time of this study.