Biomarkers
Conditions
Keywords
Bioimpedance, Body surface temperature, Blood count, C-reactive protein, Ferritin, high sensitive Troponin T, Interleukin-6, Lactate, NT-proBNP, pH, Procalcitonin, Kinetics
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.
Interventions
DEVICEDIGIPREDICT Physiopatech
Application of the DIGIPREDICT Physiopatch investigational device
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short-term kinetics of C-reactive protein | 4 days | 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. |
| Short-term kinetics of procalcitonin | 4 days | 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. |
| Short-term kinetics of interleukin-6 | 4 days | 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. |
| Short-term kinetics of ferritin | 4 days | 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. |
| Short-term kinetics of NT-pro brain natriuretic peptide | 4 days | 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. |
| Short-term kinetics of high sensitive troponin T | 4 days | 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. |
| Short-term kinetics of lactate | 4 days | 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. |
| Short-term kinetics of blood pH | 4 days | 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. |
| Short-term kinetics of body surface temperature | 4 days | 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. |
| Short-term kinetics of bioimpedance | 4 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between high sensitive troponin T and body surface temperature | 4 days | 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. |
| Correlation between high sensitive troponin T and bioimpedance | 4 days | 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. |
| Correlation between lactate and body surface temperature | 4 days | 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. |
| Correlation between C-reactive protein and body surface temperature | 4 days | 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. |
| Correlation between blood pH and body surface temperature | 4 days | 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. |
| Correlation between blood pH and bioimpedance | 4 days | 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. |
| Correlation between lactate and bioimpedance | 4 days | 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. |
| Correlation between C-reactive protein and bioimpedance | 4 days | 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. |
| Correlation between procalcitonin and body surface temperature | 4 days | 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. |
| Correlation between procalcitonin and bioimpedance | 4 days | 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. |
| Correlation between interleukin-6 and body surface temperature | 4 days | 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. |
| Correlation between interleukin-6 and bioimpedance | 4 days | 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. |
| Correlation between ferritin and body surface temperature | 4 days | 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. |
| Correlation between ferritin and bioimpedance | 4 days | 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. |
| Correlation between NT-pro brain natriuretic peptide and body surface temperature | 4 days | 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. |
| Correlation between NT-pro brain natriuretic peptide and bioimpedance | 4 days | 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. |
Outcome results
None listed