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

Not Applicable

Not yet recruiting

• Conditions: Heart Failure
• Interventions: Device: Use of the PELSA System for dISF extraction

• Registration Number: NCT06200636
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-09
• Study First Submitted QC: 2024-01-09
• Last Update Submitted: 2024-01-09
• Study First Posted: 2024-01-11
• Last Update Posted: 2024-01-11
• Study Start: 2024-03-01
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional group	Use of the PELSA System for dISF extraction	This arm inclcudes all study participants.

Primary Outcome Measures

Name	Time	Method
Detection of inflammatory and cardio-circulatory biochemical biomarkers in dermal interstitial fluid of heart failure patients	Before, immediate after and 30 min after a cardiopulmonary exercise test.	Level above the limit of quantification of the investigated biomarkers in dermal interstitial fluid.

Secondary Outcome Measures

Name	Time	Method
Relationship between the levels of biochemical inflammatory and cardio-circulatory biomarkers in dermal interstitial fluid and their blood levels in heart failure patients.	Before, immediate after and 30 min after a cardiopulmonary exercise test.	Dermal interstitial fluid levels and blood levels of the investigated biomarkers.
Safety of the PELSA system in relation to its intended use.	Before, immediate after and 30 min after a cardiopulmonary exercise test.	Documentation of adverse events and serious adverse events.
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.	Before, immediate after and 30 min after a cardiopulmonary exercise test.	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.
Performance of the PELSA system in relation to its intended use.	Before, immediate after and 30 min after a cardiopulmonary exercise test.	Evidence that the PELSA system can extract interstitial fluid from the skin.
Kinetics of inflammatory and cardio-circulatory biochemical biomarker levels in dermal interstitial fluid and in blood of heart failure patients during exercise testing.	Before, immediate after and 30 min after a cardiopulmonary exercise test.	Increase or decrease of the levels of the investigated biomarkers in dermal interstitial fluid and in blood during exercise.

Trial Locations

Locations (1)

Deutsches Herzzentrum der Charité; 🇩🇪 Berlin, Germany