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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
20
Application of the DIGIPREDICT Physiopatch investigational device
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 days