DIGIPREDICT-Physio-DE

NCT05886569 | Unknown

• 1 other identifier: DIGIPREDICT-Physio-DE
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Biomarkers

Keywords

Bioimpedance; Body surface temperature; Blood count; C-reactive protein; Ferritin; high sensitive Troponin T; Interleukin-6; Lactate; NT-proBNP; pH; Procalcitonin; Kinetics

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (16)

• Correlation between C-reactive protein and body surface temperature

  4 days

• Correlation between C-reactive protein and bioimpedance

  4 days

• Correlation between procalcitonin and body surface temperature

  4 days

• Correlation between procalcitonin and bioimpedance

  4 days

• Correlation between interleukin-6 and body surface temperature

  4 days

Study Arms (1)

Interventional group

EXPERIMENTAL

This arm includes all study participants.

Device: DIGIPREDICT Physiopatech

Interventions

DIGIPREDICT Physiopatech DEVICE

Application of the DIGIPREDICT Physiopatch investigational device

Interventional group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior physician, Transplant Outpatient Unit

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: June 2, 2023
• Study Start: May 25, 2023
• Primary Completion: November 24, 2023
• Study Completion: November 24, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-05