Skin fluid may reveal heart failure secrets without needles
NCT ID NCT06200636
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether signs of heart failure can be found in fluid just under the skin, called dermal interstitial fluid. Researchers tested 20 heart failure patients using a special device to collect this fluid during exercise. The goal was to see if these skin-based markers could one day help track the disease without needing blood draws.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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20 people
The number who actually took part.
- Started
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Apr 2024
- Finished
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Dec 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Deutsches Herzzentrum der Charité
Berlin, State of Berlin, 13353, Germany
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Other studies related to the condition(s) this trial covers.
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