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 logo

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Interventional group
Experimental group
Description:
This arm inclcudes all study participants.
Treatment:
Device: Use of the PELSA System for dISF extraction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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