Heart FailureNCT06200636
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
A study testing Use of the PELSA System for dISF extraction in people with Heart Failure, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Use of the PELSA System for dISF extraction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 16 Apr 2024to 6 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- If being of childbearing potential:
- Negative highly sensitive urine or serum pregnancy test before inclusion, and
- 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.
- Subject is capable to perform cardiopulmonary exercise testing.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Deutsches Herzzentrum der Charité
Berlin, State of Berlin, 13353
About this study
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
- Being tested
- Use of the PELSA System for dISF extraction
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of the PELSA System for dISF extractionDevice
Dermal interstitial fluid will be extracted using the investigational device, for further analysis.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | This arm inclcudes all study participants. Receives: Device: Use of the PELSA System for dISF extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Dermal interstitial fluid levels and blood levels of the investigated biomarkers.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before, immediate after and 30 min after a cardiopulmonary exercise test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start16 Apr 2024
- Primary completion6 Dec 2024
- Study completion6 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurenz Kopp Fernandes, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200636
- Sponsor's protocol ID
- DIGIPREDICT-Bio
- Status last verified
- Mar 2026
- First submitted
- 9 Jan 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06200636
- Acronym / sponsor ID
- DIGIPREDICT-Bio
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Device: Use of the PELSA System for dISF extractionThis arm inclcudes all study participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of the PELSA System for dISF extractionDermal interstitial fluid will be extracted using the investigational device, for further analysis. | Device | Interventional group |
Primary outcome
Detection of inflammatory and cardio-circulatory biochemical biomarkers in dermal interstitial fluid of heart failure patients
Time frame: 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.
5 secondary outcomes
Relationship between the levels of biochemical inflammatory and cardio-circulatory biomarkers in dermal interstitial fluid and their blood levels in heart failure patients.
Time frame: 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.
Time frame: 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.
Time frame: Before, immediate after and 30 min after a cardiopulmonary exercise test.
Performance of the PELSA system in relation to its intended use.
Time frame: Before, immediate after and 30 min after a cardiopulmonary exercise test.
Safety of the PELSA system in relation to its intended use.
Time frame: Before, immediate after and 30 min after a cardiopulmonary exercise test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of the PELSA System for dISF extraction in people with Heart Failure, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of inflammatory and cardio-circulatory biochemical biomarkers in dermal interstitial fluid of heart failure patients (time frame: Before, immediate after and 30 min after a cardiopulmonary exercise test.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.