Clinical trial NCT05886569: DIGIPREDICT-Physio-DE
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Biomarkers
Keywords: Bioimpedance
Body surface temperature
Blood count
C-reactive protein
Ferritin
high sensitive Troponin T
Interleukin-6
Lactate
NT-proBNP
pH
Procalcitonin
Kinetics
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Primary outcomes:
measure: Short-term kinetics of C-reactive protein
timeFrame: 4 days
measure: Short-term kinetics of procalcitonin
timeFrame: 4 days
measure: Short-term kinetics of interleukin-6
timeFrame: 4 days
measure: Short-term kinetics of ferritin
timeFrame: 4 days
measure: Short-term kinetics of NT-pro brain natriuretic peptide
timeFrame: 4 days
measure: Short-term kinetics of high sensitive troponin T
timeFrame: 4 days
measure: Short-term kinetics of lactate
timeFrame: 4 days
measure: Short-term kinetics of blood pH
timeFrame: 4 days
measure: Short-term kinetics of body surface temperature
timeFrame: 4 days
measure: Short-term kinetics of bioimpedance
timeFrame: 4 days
Secondary outcomes:
measure: Correlation between C-reactive protein and body surface temperature
timeFrame: 4 days
measure: Correlation between C-reactive protein and bioimpedance
timeFrame: 4 days
measure: Correlation between procalcitonin and body surface temperature
timeFrame: 4 days
measure: Correlation between procalcitonin and bioimpedance
timeFrame: 4 days
measure: Correlation between interleukin-6 and body surface temperature
timeFrame: 4 days
measure: Correlation between interleukin-6 and bioimpedance
timeFrame: 4 days
measure: Correlation between ferritin and body surface temperature
timeFrame: 4 days
measure: Correlation between ferritin and bioimpedance
timeFrame: 4 days
measure: Correlation between NT-pro brain natriuretic peptide and body surface temperature
timeFrame: 4 days
measure: Correlation between NT-pro brain natriuretic peptide and bioimpedance
timeFrame: 4 days
measure: Correlation between high sensitive troponin T and body surface temperature
timeFrame: 4 days
measure: Correlation between high sensitive troponin T and bioimpedance
timeFrame: 4 days
measure: Correlation between lactate and body surface temperature
timeFrame: 4 days
measure: Correlation between lactate and bioimpedance
timeFrame: 4 days
measure: Correlation between blood pH and body surface temperature
timeFrame: 4 days
measure: Correlation between blood pH and bioimpedance
timeFrame: 4 days
Other outcomes:
Locations:
Study officials:
References: