Clinical trial NCT06200636: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Detection of inflammatory and cardio-circulatory biochemical biomarkers in dermal interstitial fluid of heart failure patients
timeFrame: Before, immediate after and 30 min after a cardiopulmonary exercise test.
Secondary outcomes:
measure: Relationship between the levels of biochemical inflammatory and cardio-circulatory biomarkers in dermal interstitial fluid and their blood levels in heart failure patients.
timeFrame: Before, immediate after and 30 min after a cardiopulmonary exercise test.
measure: Kinetics of inflammatory and cardio-circulatory biochemical biomarker levels in dermal interstitial fluid and in blood of heart failure patients during exercise testing.
timeFrame: Before, immediate after and 30 min after a cardiopulmonary exercise test.
measure: Relationship between kinetics of inflammatory and cardio-circulatory biochemical biomarker levels in dermal interstitial fluid and in blood of heart failure patients during exercise testing.
timeFrame: Before, immediate after and 30 min after a cardiopulmonary exercise test.
measure: Performance of the PELSA system in relation to its intended use.
timeFrame: Before, immediate after and 30 min after a cardiopulmonary exercise test.
measure: Safety of the PELSA system in relation to its intended use.
timeFrame: Before, immediate after and 30 min after a cardiopulmonary exercise test.
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Deutsches Herzzentrum der Charité
Study officials:
References: