CompletedNot Applicable

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

Germany20 participantsStarted 2024-04-16

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

What they're measuring

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.

Trial details

NCT IDNCT06200636

SponsorCharite University, Berlin, Germany

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-06

View on ClinicalTrials.gov More Heart Failure trials