DIGIPREDICT-Physio-DE

Charité University Medicine Berlin

Status

Not yet enrolling

Conditions

Biomarkers

Treatments

Device: DIGIPREDICT Physiopatech

Study type

Interventional

Funder types

Other

Identifiers

NCT05886569

DIGIPREDICT-Physio-DE

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.