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

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:

• 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 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.