Using skin fluid to diagnose and monitor heart diseases
Biomarkers in Dermal Interstitial Fluid for Early Diagnosis and Follow-up of Cardiovascular Diseases
This study is testing if skin fluid can help doctors find early signs of heart disease and monitor heart health in older adults with heart failure compared to younger people without heart issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ascilion AB Industry-sponsored |
| Locations | 1 site (Danderyd) |
| Trial ID | NCT06632353 on ClinicalTrials.gov |
What this trial studies
This observational study involves sampling dermal interstitial fluid (dISF) and blood plasma to investigate biomarkers that could aid in the early diagnosis and follow-up of cardiovascular diseases. Participants will be divided into two groups: one consisting of older adults with chronic heart failure and another of younger individuals without known heart conditions. The study aims to identify potential biomarkers in dISF that correlate with cardiovascular health. The methodology focuses on qualitative measurements to assess the effectiveness of these biomarkers.
Who should consider this trial
Good fit: Ideal candidates include individuals over 60 years with stable chronic heart failure or younger adults aged 18-40 without known heart or vascular diseases.
Not a fit: Patients with severe skin injuries, known heart or vascular diseases, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate diagnoses of cardiovascular diseases, improving patient outcomes.
How similar studies have performed: While the use of biomarkers in blood plasma for cardiovascular diseases has been explored, the specific approach of using dISF is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: Group 1: Chronic heart failure with stable therapy. NYHA classification III and IV. Age \> 60 years. Group 2: Age 18-40 years. Exclusion criteria: * Participating in another clinical investigation which may affect the study outcome according to clinical judgement. * Previous use of sampling system used. * Pregnancy or lactating. * Any disease or condition that may be affected. * Individuals who lack the ability to fully consent to participate in the study. * Severe skin injury. * Tattoo or piercing close to sampling area. * Group 1: All forms of emergency care. * Group 1: Non-stable therapy. * Group 1: Sepsis. * Group 1: BMI \> 30kg/m2. * Group 1: Age \> 84 years. * Group 2: Known heart or vascular disease. * Group 2: Diabetes. * Group 2: Kidney disease.
Where this trial is running
Danderyd
- Danderyd Hospital — Danderyd, Sweden (Recruiting)
Study contacts
- Study coordinator: Mikael Hillmering, PhD
- Email: mikael.hillmering@ascilion.com
- Phone: +46703018923
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.