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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06200636
• Other study ID #: DIGIPREDICT-Bio
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: November 1, 2024

Study information

• Verified date: January 2024
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Disease Progression
• Heart Failure

Intervention

Device:
• Use of the PELSA System for dISF extraction
Dermal interstitial fluid will be extracted using the investigational device, for further analysis.

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum der Charité	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.