NCT06200636Completed
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
Source: ClinicalTrials.gov · Last updated 12 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 9 Jan 2024
- Start date
- 16 Apr 2024
- Primary completion date
- 6 Dec 2024
- Lead sponsor
- Charite University, Berlin, Germany
- Diseases
- Heart failure
- NCT number
- NCT06200636
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 16 Apr 2024 to the primary completion date, 6 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subject is treated with immunosuppressive drugs at enrolment.
- Subject requires renal replacement therapy.
- Subject participates in a study according to AMG/CTR that investigates immunosuppressive or anticoagulant drugs at the time of this study.
Other illness
- Subject suffers from an addiction or from a disease that prevents the subject from recognizing nature, scope, and consequences of the study.
- Subject has a known colonisation or infection with multi-drug-resistant pathogens.
Other
- Subject is breastfeeding.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Deutsches Herzzentrum der Charité Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.