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

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 Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Use of the PELSA System for dISF extraction

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • State of Berlin
    • Berlin, State of Berlin, Germany, 13353
      • Deutsches Herzzentrum der Charite

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional group; This arm inclcudes all study participants.	Device: Use of the PELSA System for dISF extraction; Dermal interstitial fluid will be extracted using the investigational device, for further analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.
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.

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2024
• Primary Completion (Actual): December 6, 2024
• Study Completion (Actual): December 6, 2024

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: January 9, 2024
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: DIGIPREDICT-Bio

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No