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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.
Enrollment
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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%):
Subject is capable to perform cardiopulmonary exercise testing.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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