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Cardiovascular Risk in Children With Chronic Conditions Study

Cardiovascular Risk in Children With Chronic Conditions Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07086989
Acronym
CR3C
Enrollment
300
Registered
2025-07-25
Start date
2025-04-01
Completion date
2029-01-31
Last updated
2025-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aorta Stenosis, Bone Marrow Transplant, Cancer (Solid Tumors), Chronic Kidney Disease, Coarctation of Aorta, Dyslipaemia, Familial Hypercholesterolaemia, HIV Infection, Hypertension, Inflammatory Bowel Disease (IBD), Juvenile Idiopahtic Arthritis, Kawasaki Disease, Kidney Transplant, Leukemia, Lipoprotein(a), Liver Transplant, Lymphoma, Non Alcoholic Fatty Liver Disease, Obesity and Overweight, Pulmonary Hypertension, Systemic Lupus Erthematosus, Transposition of Great Arteries, Type 1 Diabetes Mellitus (T1DM), Type 2 Diabetes Mellitus (T2DM), White Coat Hypertension

Keywords

cardiovascular risk, vasculature, children with chronic conditions

Brief summary

Children living with chronic health conditions face a higher risk of developing cardiovascular diseases than their peers, largely due to the accelerated aging of the heart and blood vessels. Although experts recognize this elevated risk and recommend close monitoring and early intervention, the underlying mechanisms driving this phenomenon remain poorly understood. At present, no effective interventions specifically target its root causes. Recent research shows that both large blood vessels (such as the carotid artery) and small vessels (such as those in the retina) can display early signs of damage decades before clinically apparent heart or vascular disease emerges. This accelerated vascular aging can result from multiple factors - including disease-related processes such as persistent inflammation and metabolic disturbances, treatment-related effects such as chemotherapy or long-term steroid use, and lifestyle changes associated with chronic illness, such as reduced physical activity and altered eating habits. However, it is still unclear how these factors influence the development and progression of vascular changes in children as they grow. Importantly, these changes can be monitored through non-invasive methods, offering a unique opportunity to study at-risk patients many years before overt cardiovascular disease develops. Identifying these early changes may enable us to detect and track individuals at heightened risk well in advance of clinical disease. This study aims to deepen our understanding of the causes of increased cardiovascular risk in children with chronic conditions and to lay the groundwork for earlier, more targeted prevention strategies.

Interventions

None listed

Sponsors

Semmelweis University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 25 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Arterial stiffnessAt baseline and at the time of annual follow-upAssessed by carotid-femoral pulse wave velocity
Endothelial function of the brachial arteryAt baseline and at the time of annual follow-upEvaluated using flow-mediated dilation measured by ultrasound
Retinal vessel diameterAt baseline and at the time of annual follow-upAssessed by static retinal vessel analysis
Retinal vessel fractal dimension and tortuosityAt baseline and at the time of annual follow-upAssessed by static retinal vessel analysis

Secondary

MeasureTime frameDescription
Endothelial function in capillariesAt baseline and at the time of annual follow-upAssessed by flow-mediated dilation using laser speckle contrast imaging
Retinal neurovascular couplingAt baseline and at the time of annual follow-upAssessed by dynamic retinal vessel analysis

Countries

Hungary

Contacts

Primary ContactTamas Kiss, MD, PhD
kiss.tamas1@semmelweis.hu+36202478885
Backup ContactBálint Mikes, MD, PhD
mikes.balint1@semmelweis.hu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026