DIGIPREDICT-Physio-DE | NCT05886569

NCT05886569

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
Interventional group	Experimental	This arm includes all study participants.	Device: DIGIPREDICT Physiopatech

Name	Type	Description	Arm Group Labels	Other Names
DIGIPREDICT Physiopatech	Device	Application of the DIGIPREDICT Physiopatch investigational device	Interventional group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Short-term kinetics of C-reactive protein	Outcome is the detection of kinetics of C-reactive protein values [mg/L] between at least two timestamps. Short-term is defined as <= 26hours; biomarker kinetics are defined as >20% increase or decrease of a biomarker level at one point in time compared to the level at another point in time. The timestamp documented in the electronic health record will be used for analysis.	4 days
Short-term kinetics of procalcitonin	Outcome is the detection of kinetics of procalcitonin values [ng/mL] between at least two timestamps. Short-term is defined as <= 26hours; biomarker kinetics are defined as >20% increase or decrease of a biomarker level at one point in time compared to the level at another point in time. The timestamp documented in the electronic health record will be used for analysis.	4 days
Short-term kinetics of interleukin-6	Outcome is the detection of kinetics of interleukin-6 values [ng/L] between at least two timestamps. Short-term is defined as <= 26hours; biomarker kinetics are defined as >20% increase or decrease of a biomarker level at one point in time compared to the level at another point in time. The timestamp documented in the electronic health record will be used for analysis.	4 days
Short-term kinetics of ferritin	Outcome is the detection of kinetics of ferritin values [µg/L] between at least two timestamps. Short-term is defined as <= 26hours; biomarker kinetics are defined as >20% increase or decrease of a biomarker level at one point in time compared to the level at another point in time. The timestamp documented in the electronic health record will be used for analysis.	4 days
Short-term kinetics of NT-pro brain natriuretic peptide

Secondary Outcomes

Measure	Description	Time Frame
Correlation between C-reactive protein and body surface temperature	Outcome is the detection of a correlation between C-reactive protein [mg/L] and body surface temperature [°C]. Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days

Eligibility Module

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.