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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional group | Experimental | This arm inclcudes all study participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of the PELSA System for dISF extraction | Device | Dermal interstitial fluid will be extracted using the investigational device, for further analysis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detection of inflammatory and cardio-circulatory biochemical biomarkers in dermal interstitial fluid of heart failure patients | Level above the limit of quantification of the investigated biomarkers in dermal interstitial fluid. | Before, immediate after and 30 min after a cardiopulmonary exercise test. |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship between the levels of biochemical inflammatory and cardio-circulatory biomarkers in dermal interstitial fluid and their blood levels in heart failure patients. | Dermal interstitial fluid levels and blood levels of the investigated biomarkers. | Before, immediate after and 30 min after a cardiopulmonary exercise test. |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Herzzentrum der Charité | Berlin | State of Berlin | 13353 | Germany |
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| Kinetics of inflammatory and cardio-circulatory biochemical biomarker levels in dermal interstitial fluid and in blood of heart failure patients during exercise testing. |
Increase or decrease of the levels of the investigated biomarkers in dermal interstitial fluid and in blood during exercise. |
| Before, immediate after and 30 min after a cardiopulmonary exercise test. |
| Relationship between kinetics of inflammatory and cardio-circulatory biochemical biomarker levels in dermal interstitial fluid and in blood of heart failure patients during exercise testing. | Dermal interstitial fluid level change (to first or previous measurement) and blood level change (to first or previous measurement) of the investigated biomarkers during exercise. | Before, immediate after and 30 min after a cardiopulmonary exercise test. |
| Performance of the PELSA system in relation to its intended use. | Evidence that the PELSA system can extract interstitial fluid from the skin. | Before, immediate after and 30 min after a cardiopulmonary exercise test. |
| Safety of the PELSA system in relation to its intended use. | Documentation of adverse events and serious adverse events. | Before, immediate after and 30 min after a cardiopulmonary exercise test. |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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