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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05886569
Other study ID # DIGIPREDICT-Physio-DE
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 25, 2023
Est. completion date November 24, 2023

Study information

Verified date May 2023
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date November 24, 2023
Est. primary completion date November 24, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
DIGIPREDICT Physiopatech
Application of the DIGIPREDICT Physiopatch investigational device

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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