DIGIPREDICT-Physio-DE

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Biomarkers
• Intervention / Treatment: Device: DIGIPREDICT Physiopatech

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional group; This arm includes all study participants.	Device: DIGIPREDICT Physiopatech; Application of the DIGIPREDICT Physiopatch investigational device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	Outcome is the detection of kinetics of NT-pro brain natriuretic peptide [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 high sensitive troponin T	Outcome is the detection of kinetics of high sensitive troponin T [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 lactate	Outcome is the detection of kinetics of lactate [mg/dL] 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 blood pH	Outcome is the detection of kinetics of blood pH 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 body surface temperature	Outcome is the detection of kinetics of body surface temperature [°C] between at least two timestamps. The mean value within 1 h before the timestamp of the concomitant biochemical biomarkers will be used for analysis. 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 bioimpedance	Outcome is the detection of kinetics of bioimpedance [Ohm] between at least two timestamps. The mean value within 1 h before the timestamp of the concomitant biochemical biomarkers will be used for analysis. 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

Secondary Outcome Measures

Outcome Measure	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
Correlation between C-reactive protein and bioimpedance	Outcome is the detection of a correlation between C-reactive protein [mg/L] and bioimpedance [Ohm]. Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days
Correlation between procalcitonin and body surface temperature	Outcome is the detection of a correlation between procalcitonin [ng/mL] and body surface temperature [°C]. Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days
Correlation between procalcitonin and bioimpedance	Outcome is the detection of a correlation between procalcitonin [ng/mL] and bioimpedance [Ohm]. Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days
Correlation between interleukin-6 and body surface temperature	Outcome is the detection of a correlation between interleukin-6 [ng/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
Correlation between interleukin-6 and bioimpedance	Outcome is the detection of a correlation between interleukin-6 [ng/L] and bioimpedance [Ohm]. Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days
Correlation between ferritin and body surface temperature	Outcome is the detection of a correlation between ferritin [µg/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
Correlation between ferritin and bioimpedance	Outcome is the detection of a correlation between ferritin [µg/L] and bioimpedance [Ohm]. Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days
Correlation between NT-pro brain natriuretic peptide and body surface temperature	Outcome is the detection of a correlation between NT-pro brain natriuretic peptide [ng/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
Correlation between NT-pro brain natriuretic peptide and bioimpedance	Outcome is the detection of a correlation between NT-pro brain natriuretic peptide [ng/L] and bioimpedance [Ohm]. Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days
Correlation between high sensitive troponin T and body surface temperature	Outcome is the detection of a correlation high sensitive troponin T [ng/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
Correlation between high sensitive troponin T and bioimpedance	Outcome is the detection of a correlation high sensitive troponin T [ng/L] and bioimpedance [Ohm]. Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days
Correlation between lactate and body surface temperature	Outcome is the detection of a correlation between lactate [mg/dL] and body surface temperature [°C]. Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days
Correlation between lactate and bioimpedance	Outcome is the detection of a correlation between lactate [mg/dL] and bioimpedance [Ohm]. Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days
Correlation between blood pH and body surface temperature	Outcome is the detection of a correlation between blood pH and body surface temperature [°C]. Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days
Correlation between blood pH and bioimpedance	Outcome is the detection of a correlation between blood pH and bioimpedance [Ohm]. Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Estimated): May 25, 2023
• Primary Completion (Estimated): November 24, 2023
• Study Completion (Estimated): November 24, 2023

Study Registration Dates

• First Submitted: May 12, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Actual): June 2, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Procalcitonin; C-reactive protein; Lactate; Interleukin-6; pH; Ferritin; NT-proBNP; Bioimpedance; Kinetics; Blood count; Body surface temperature; high sensitive Troponin T
• Other Study ID Numbers: DIGIPREDICT-Physio-DE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No