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

NCT06200636 | Completed

• 1 other identifier: DIGIPREDICT-Bio
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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.

• 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.

• 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.

• Performance of the PELSA system in relation to its intended use.

  Before, immediate after and 30 min after a cardiopulmonary exercise test.

• Safety of the PELSA system in relation to its intended use.

  Before, immediate after and 30 min after a cardiopulmonary exercise test.

Study Arms (1)

Interventional group

EXPERIMENTAL

This arm inclcudes all study participants.

Device: Use of the PELSA System for dISF extraction

Interventions

Use of the PELSA System for dISF extraction DEVICE

Dermal interstitial fluid will be extracted using the investigational device, for further analysis.

Interventional group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Practicing a highly effective birth control method (failure rate of less than 1%):
• combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral/intravaginal/ transdermal), or
• progestogen-only hormonal contraception associated with inhibition of ovulation (oral/injectable/implantable), or
• intrauterine device (IUD), or
• intrauterine hormone-releasing system (IUS), or
• bilateral tubal occlusion, or
• vasectomised partner, or
• heterosexual abstinence.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Deutsches Herzzentrum der Charité

Berlin, State of Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior physician, Transplant Outpatient Unit

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 11, 2024
• Study Start: April 16, 2024
• Primary Completion: December 6, 2024
• Study Completion: December 6, 2024
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)