Cardiovascular health in children and young adults with chronic conditions
Cardiovascular Risk in Children With Chronic Conditions Study
This project will see if children and young adults (ages 6-25) with chronic health conditions show early signs of aging in large and small blood vessels using noninvasive imaging and clinical tests.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 6 Years to 25 Years |
| Sex | All |
| Sponsor | Semmelweis University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Budapest and 2 other locations) |
| Trial ID | NCT07086989 on ClinicalTrials.gov |
What this trial studies
This observational study will enroll participants aged 6-25 who have chronic childhood conditions linked to higher cardiovascular risk. Investigators will use noninvasive measures such as carotid artery imaging and retinal vessel imaging alongside clinical measures of inflammation and metabolic status to characterize vascular aging. The study will consider disease-related factors (for example diabetes or chronic kidney disease), treatment-related effects (such as long-term steroids or chemotherapy), and lifestyle-related contributors. The goal is to identify early vascular markers and underlying mechanisms that could guide future monitoring and prevention strategies.
Who should consider this trial
Good fit: Children and young adults aged 6-25 with chronic childhood conditions linked to higher early cardiovascular risk (for example type 1 or type 2 diabetes, chronic kidney disease, kidney transplant history, or familial hypercholesterolaemia) are ideal candidates.
Not a fit: Patients with severe intellectual or developmental disability, decompensated heart failure, severe primary immunodeficiency, ongoing intravenous chemotherapy, active infectious diseases posing public-health risk, or those outside the 6-25 age range are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could identify early vascular changes and markers that help clinicians target monitoring and preventive care to reduce future heart and blood vessel disease.
How similar studies have performed: Previous observational studies have detected early carotid and retinal vascular changes in some chronic conditions, but interventions targeting these mechanisms are still largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. Individuals aged between 6 and 25 years; 2. Diagnosed with a chronic childhood condition/disease associated with an increased risk of early cardiovascular disease; 3. Provided informed consent (if over 18 years old) or had informed consent provided by their legal guardian (if under 18 years old) following appropriate information about the study. Chronic childhood conditions/diseases associated with increased risk of early cardiovascular disease are defined according to the 2019 American Heart Association recommendations (https://doi.org/10.1161/CIR.0000000000000618), as well as other conditions/diseases for which at least two large-scale epidemiological studies have demonstrated an increased risk of cardiovascular disease. Exclusion criteria: 1. Severe intellectual and developmental disability; 2. Decompensated heart failure; 3. Severe primary immunodeficiency; 4. Ongoing intravenous chemotherapy; 5. Infectious diseases posing a public health risk; or 6. History of regular alcohol or drug use.
Where this trial is running
Budapest and 2 other locations
- Semmelweis University, Department of Surgery, Transplantation and Gastroenterology — Budapest, Hungary (Not_yet_recruiting)
- Semmelweis University, Pediatric Center — Budapest, Hungary (Recruiting)
- Semmelweis University, Institute of Preventive Medicine and Public Health — Budapest, Hungary (Active_not_recruiting)
Study contacts
- Principal investigator: Tamas Kiss, MD, PhD — Semmelweis University, Pediatric Center
- Study coordinator: Tamas Kiss, MD, PhD
- Email: kiss.tamas1@semmelweis.hu
- Phone: +36202478885
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.