Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT05886569
Status:
UNKNOWN
Last Update Posted:
2023-06-02
First Post:
2023-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DIGIPREDICT-Physio-DE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-11-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-23', 'studyFirstSubmitDate': '2023-05-12', 'studyFirstSubmitQcDate': '2023-05-23', 'lastUpdatePostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short-term kinetics of C-reactive protein', 'timeFrame': '4 days', 'description': 'Outcome is the detection of kinetics of C-reactive protein values \\[mg/L\\] between at least two timestamps.\n\nShort-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.'}, {'measure': 'Short-term kinetics of procalcitonin', 'timeFrame': '4 days', 'description': 'Outcome is the detection of kinetics of procalcitonin values \\[ng/mL\\] between at least two timestamps.\n\nShort-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.'}, {'measure': 'Short-term kinetics of interleukin-6', 'timeFrame': '4 days', 'description': 'Outcome is the detection of kinetics of interleukin-6 values \\[ng/L\\] between at least two timestamps.\n\nShort-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.'}, {'measure': 'Short-term kinetics of ferritin', 'timeFrame': '4 days', 'description': 'Outcome is the detection of kinetics of ferritin values \\[µg/L\\] between at least two timestamps.\n\nShort-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.'}, {'measure': 'Short-term kinetics of NT-pro brain natriuretic peptide', 'timeFrame': '4 days', 'description': 'Outcome is the detection of kinetics of NT-pro brain natriuretic peptide \\[ng/L\\] between at least two timestamps.\n\nShort-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.'}, {'measure': 'Short-term kinetics of high sensitive troponin T', 'timeFrame': '4 days', 'description': 'Outcome is the detection of kinetics of high sensitive troponin T \\[ng/L\\] between at least two timestamps.\n\nShort-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.'}, {'measure': 'Short-term kinetics of lactate', 'timeFrame': '4 days', 'description': 'Outcome is the detection of kinetics of lactate \\[mg/dL\\] between at least two timestamps.\n\nShort-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.'}, {'measure': 'Short-term kinetics of blood pH', 'timeFrame': '4 days', 'description': 'Outcome is the detection of kinetics of blood pH between at least two timestamps.\n\nShort-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.'}, {'measure': 'Short-term kinetics of body surface temperature', 'timeFrame': '4 days', 'description': '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.\n\nShort-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.'}, {'measure': 'Short-term kinetics of bioimpedance', 'timeFrame': '4 days', 'description': '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.\n\nShort-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.'}], 'secondaryOutcomes': [{'measure': 'Correlation between C-reactive protein and body surface temperature', 'timeFrame': '4 days', 'description': "Outcome is the detection of a correlation between C-reactive protein \\[mg/L\\] and body surface temperature \\[°C\\].\n\nCorrelations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient."}, {'measure': 'Correlation between C-reactive protein and bioimpedance', 'timeFrame': '4 days', 'description': "Outcome is the detection of a correlation between C-reactive protein \\[mg/L\\] and bioimpedance \\[Ohm\\].\n\nCorrelations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient."}, {'measure': 'Correlation between procalcitonin and body surface temperature', 'timeFrame': '4 days', 'description': "Outcome is the detection of a correlation between procalcitonin \\[ng/mL\\] and body surface temperature \\[°C\\].\n\nCorrelations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient."}, {'measure': 'Correlation between procalcitonin and bioimpedance', 'timeFrame': '4 days', 'description': "Outcome is the detection of a correlation between procalcitonin \\[ng/mL\\] and bioimpedance \\[Ohm\\].\n\nCorrelations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient."}, {'measure': 'Correlation between interleukin-6 and body surface temperature', 'timeFrame': '4 days', 'description': "Outcome is the detection of a correlation between interleukin-6 \\[ng/L\\] and body surface temperature \\[°C\\].\n\nCorrelations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient."}, {'measure': 'Correlation between interleukin-6 and bioimpedance', 'timeFrame': '4 days', 'description': "Outcome is the detection of a correlation between interleukin-6 \\[ng/L\\] and bioimpedance \\[Ohm\\].\n\nCorrelations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient."}, {'measure': 'Correlation between ferritin and body surface temperature', 'timeFrame': '4 days', 'description': "Outcome is the detection of a correlation between ferritin \\[µg/L\\] and body surface temperature \\[°C\\].\n\nCorrelations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient."}, {'measure': 'Correlation between ferritin and bioimpedance', 'timeFrame': '4 days', 'description': "Outcome is the detection of a correlation between ferritin \\[µg/L\\] and bioimpedance \\[Ohm\\].\n\nCorrelations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient."}, {'measure': 'Correlation between NT-pro brain natriuretic peptide and body surface temperature', 'timeFrame': '4 days', 'description': "Outcome is the detection of a correlation between NT-pro brain natriuretic peptide \\[ng/L\\] and body surface temperature \\[°C\\].\n\nCorrelations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient."}, {'measure': 'Correlation between NT-pro brain natriuretic peptide and bioimpedance', 'timeFrame': '4 days', 'description': "Outcome is the detection of a correlation between NT-pro brain natriuretic peptide \\[ng/L\\] and bioimpedance \\[Ohm\\].\n\nCorrelations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient."}, {'measure': 'Correlation between high sensitive troponin T and body surface temperature', 'timeFrame': '4 days', 'description': "Outcome is the detection of a correlation high sensitive troponin T \\[ng/L\\] and body surface temperature \\[°C\\].\n\nCorrelations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient."}, {'measure': 'Correlation between high sensitive troponin T and bioimpedance', 'timeFrame': '4 days', 'description': "Outcome is the detection of a correlation high sensitive troponin T \\[ng/L\\] and bioimpedance \\[Ohm\\].\n\nCorrelations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient."}, {'measure': 'Correlation between lactate and body surface temperature', 'timeFrame': '4 days', 'description': "Outcome is the detection of a correlation between lactate \\[mg/dL\\] and body surface temperature \\[°C\\].\n\nCorrelations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient."}, {'measure': 'Correlation between lactate and bioimpedance', 'timeFrame': '4 days', 'description': "Outcome is the detection of a correlation between lactate \\[mg/dL\\] and bioimpedance \\[Ohm\\].\n\nCorrelations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient."}, {'measure': 'Correlation between blood pH and body surface temperature', 'timeFrame': '4 days', 'description': "Outcome is the detection of a correlation between blood pH and body surface temperature \\[°C\\].\n\nCorrelations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient."}, {'measure': 'Correlation between blood pH and bioimpedance', 'timeFrame': '4 days', 'description': "Outcome is the detection of a correlation between blood pH and bioimpedance \\[Ohm\\].\n\nCorrelations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bioimpedance', 'Body surface temperature', 'Blood count', 'C-reactive protein', 'Ferritin', 'high sensitive Troponin T', 'Interleukin-6', 'Lactate', 'NT-proBNP', 'pH', 'Procalcitonin', 'Kinetics'], 'conditions': ['Biomarkers']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n* 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.\n* Age of subject is ≥ 18years.\n* Subject is female, male, divers.\n* Signed written informed consent.\n* For female subject or divers subject:\n\n 1. Negative highly sensitive urine or serum pregnancy test before inclusion, and\n 2. Practicing a highly effective birth control method (failure rate of less than 1%):\n\n 1. combined (estrogen and progestogen containing) hormonal\n 2. contraception associated with inhibition of ovulation (oral/intravaginal/ transdermal), or\n 3. progestogen-only hormonal contraception associated with inhibition of ovulation (oral/injectable/implantable), or\n 4. intrauterine device (IUD), or\n 5. intrauterine hormone-releasing system ( IUS), or\n 6. bilateral tubal occlusion, or\n 7. vasectomised partner, or\n 8. heterosexual abstinence.\n\nExclusion Criteria:\n\n* Subject is breastfeeding.\n* Subject suffers from an addiction or from a disease that prevents the subject from recognizing nature, scope, and consequences of the study.\n* Subject is treated with immunosuppressive drugs at enrolment.\n* Subject requires mechanical circulatory support at enrolment (IABP, veno-arterial ECMO, Impella, VAD, TAH).\n* Subject requires extracorporeal lung support at enrolment (veno-venous ECMO, interventional lung assist).\n* Subject requires invasive ventilation at enrolment.\n* Subject requires renal replacement therapy.\n* Subjects with an active stimulation device (implanted or not) (e.g. pacemaker, nerve stimulator).\n* Subject has a known colonisation or infection with multi-drug-resistant pathogens.\n* Subject suffers from a skin disease at all possible placement sites for the DIGIPREDICT Physiopatch.\n\nSubject has damaged skin at all fingertips.\n\n* Subject has highly sensitive skin to (medical) adhesives.\n* Subject shows an inability to comply with all of the study procedures and follow-up visits.\n* Subjects who are unwilling to consent to saving and propagation of pseudonymised medical data for study reasons.\n* Subject is legally detained in an official institution.\n* Subject is dependent on the sponsor, the investigator or the study sites.\n* 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.'}, 'identificationModule': {'nctId': 'NCT05886569', 'briefTitle': 'DIGIPREDICT-Physio-DE', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'DIGIPREDICT-Physio-DE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional group', 'description': 'This arm includes all study participants.', 'interventionNames': ['Device: DIGIPREDICT Physiopatech']}], 'interventions': [{'name': 'DIGIPREDICT Physiopatech', 'type': 'DEVICE', 'description': 'Application of the DIGIPREDICT Physiopatch investigational device', 'armGroupLabels': ['Interventional group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior physician, Transplant Outpatient Unit', 'investigatorFullName': 'Laurenz Kopp Fernandes', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}