BiomarkersNCT05886569
DIGIPREDICT-Physio-DE
A study testing DIGIPREDICT Physiopatech in people with Biomarkers, run by Charite University, Berlin, Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biomarkers
- What is being tested?
- DIGIPREDICT Physiopatech
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2023to 24 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- Negative highly sensitive urine or serum pregnancy test before inclusion, and
- Practicing a highly effective birth control method (failure rate of less than 1%):
- combined (estrogen and progestogen containing) hormonal
- contraception associated with inhibition of ovulation (oral/intravaginal/ transdermal), or
- progestogen-only hormonal contraception associated with inhibition of ovulation (oral/injectable/implantable), or
- intrauterine device (IUD), or
- intrauterine hormone-releasing system ( IUS), or
- bilateral tubal occlusion, or
- vasectomised partner, or
- heterosexual abstinence.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
About this study
Official title: 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.
- Conditions
- Biomarkers
- Being tested
- DIGIPREDICT Physiopatech
- Keywords
- Bioimpedance, Body surface temperature, Blood count, C-reactive protein, Ferritin, high sensitive Troponin T, Interleukin-6, Lactate, NT-proBNP, pH, Procalcitonin, Kinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIGIPREDICT PhysiopatechDevice
Application of the DIGIPREDICT Physiopatch investigational device
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | This arm includes all study participants. Receives: Device: DIGIPREDICT Physiopatech |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 days
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start25 May 2023 (estimated)
- Primary completion24 Nov 2023 (estimated)
- Study completion24 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiomarkersStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurenz Kopp Fernandes, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886569
- Sponsor's protocol ID
- DIGIPREDICT-Physio-DE
- Status last verified
- May 2023
- First submitted
- 12 May 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05886569
- Acronym / sponsor ID
- DIGIPREDICT-Physio-DE
- Conditions
- Biomarkers
- Keywords
- Bioimpedance, Body surface temperature, Blood count, C-reactive protein, Ferritin, high sensitive Troponin T, Interleukin-6, Lactate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 25 May 2023 (estimated)
- Primary completion
- 24 Nov 2023 (estimated)
- Study completion
- 24 Nov 2023 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Device: DIGIPREDICT PhysiopatechThis arm includes all study participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DIGIPREDICT PhysiopatechApplication of the DIGIPREDICT Physiopatch investigational device | Device | Interventional group |
Primary outcome
Short-term kinetics of C-reactive protein
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
16 secondary outcomes
Correlation between C-reactive protein and body surface temperature
Time frame: 4 days
Correlation between C-reactive protein and bioimpedance
Time frame: 4 days
Correlation between procalcitonin and body surface temperature
Time frame: 4 days
Correlation between procalcitonin and bioimpedance
Time frame: 4 days
Correlation between interleukin-6 and body surface temperature
Time frame: 4 days
Correlation between interleukin-6 and bioimpedance
Time frame: 4 days
Correlation between ferritin and body surface temperature
Time frame: 4 days
Correlation between ferritin and bioimpedance
Time frame: 4 days
Correlation between NT-pro brain natriuretic peptide and body surface temperature
Time frame: 4 days
Correlation between NT-pro brain natriuretic peptide and bioimpedance
Time frame: 4 days
Correlation between high sensitive troponin T and body surface temperature
Time frame: 4 days
Correlation between high sensitive troponin T and bioimpedance
Time frame: 4 days
Correlation between lactate and body surface temperature
Time frame: 4 days
Correlation between lactate and bioimpedance
Time frame: 4 days
Correlation between blood pH and body surface temperature
Time frame: 4 days
Correlation between blood pH and bioimpedance
Time frame: 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing DIGIPREDICT Physiopatech in people with Biomarkers, run by Charite University, Berlin, Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term kinetics of C-reactive protein (time frame: 4 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.