digipredict-physio-de

Conditions: Biomarkers

Summary: the study aims to investigate short-term physiological and biochemical inflammatory and cardiocirculatory biomarker kinetics in heart failure patients, using the digipredict physiopatch device - an investigational device that allows non-invasive realtime single-lead ecg registration and bioimpedance measurement as well as spotcheck photoplethysmography -, and standard laboratory methods, respectively.


Eligibility criteria:
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.

Keywords: bioimpedance body surface temperature blood count c-reactive protein ferritin high sensitive troponin t interleukin-6 lactate nt-probnp ph procalcitonin kinetics