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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
20
Dermal interstitial fluid will be extracted using the investigational device, for further analysis.
Deutsches Herzzentrum der Charité
Berlin, State of Berlin, Germany
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.
Time frame: Before, immediate after and 30 min after a cardiopulmonary exercise test.
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.
Time frame: Before, immediate after and 30 min after a cardiopulmonary exercise test.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Before, immediate after and 30 min after a cardiopulmonary exercise test.
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