Edge AI-deployed DIGItal Twins for PREDICTing Disease Progression and Need for Early Intervention in Infectious and Cardiovascular Diseases Beyond COVID-19 - Investigation of Biomarkers in Dermal Interstitial Fluid

Charité University Medicine Berlin

Status

Not yet enrolling

Conditions

Heart Failure

Treatments

Device: Use of the PELSA System for dISF extraction

Study type

Interventional

Funder types

Other

Identifiers

NCT06200636

DIGIPREDICT-Bio

Details and patient eligibility

About

The study will investigate, if inflammatory and cardio-circulatory biochemical biomarkers are detectable in dermal interstitial fluid (dISF) of heart failure patients, and if there are detectable kinetics of these biomarkers during a cardiopulmonary exercise test. For dISF extraction the PELSA System - an investigational device - will be used.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject suffers from heart failure (according to ESC 2021 Heart Failure Guidelines).
Age of subject is ≥18 years.
Subject is female or male.
Signed written informed consent.
For female subjects:
1. Confirmed post-menopausal state, defined as amenorrhea for at least 12 months, or
2. If being of childbearing potential:
  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 contraception associated with inhibition of ovulation (oral/intravaginal/ transdermal), or
    2. progestogen-only hormonal contraception associated with inhibition of ovulation (oral/injectable/implantable), or
    3. intrauterine device (IUD), or
    4. intrauterine hormone-releasing system (IUS), or
    5. bilateral tubal occlusion, or
    6. vasectomised partner, or
    7. heterosexual abstinence.
Subject is capable to perform cardiopulmonary exercise testing.

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 renal replacement therapy.
Subject has a known colonisation or infection with multi-drug-resistant pathogens.
Subject has an open wound in or near the sampling area.
Subject has any type of tattoo or piercing anywhere in or near the sampling area.
Subject shows an inability to comply with all the study procedures and follow-up visits.
Subject is 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 a study according to AMG/CTR that investigates immunosuppressive or anticoagulant drugs at the time of this study.