Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 kine...
Eligibility Criteria
Inclusion
- 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:
- Confirmed post-menopausal state, defined as amenorrhea for at least 12 months, or
- If being of childbearing potential:
- Negative highly sensitive urine or serum pregnancy test before inclusion, and
- 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.
- Subject is capable to perform cardiopulmonary exercise testing.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06200636
Start Date
March 1 2024
End Date
November 1 2024
Last Update
January 11 2024
Active Locations (1)
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1
Deutsches Herzzentrum der Charité
Berlin, Germany, 13353