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

NCT ID: NCT06200636

Last Updated: 2024-01-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-11-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Interventional group

This arm inclcudes all study participants.

Group Type: EXPERIMENTAL

Use of the PELSA System for dISF extraction

Intervention Type: DEVICE

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

Interventions

Use of the PELSA System for dISF extraction

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Laurenz Kopp Fernandes

Senior physician, Transplant Outpatient Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Deutsches Herzzentrum der Charité

Berlin, , Germany

Countries

Germany

Other Identifiers

DIGIPREDICT-Bio

Identifier Type: -

Identifier Source: org_study_id