Clinical trial

Cardiovascular Risk in Children With Chronic Conditions Study

Recruiting now · Not applicable · 1 countries · Registry ID NCT07086989

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age6 Years to 25 Years

SexAll

Healthy volunteersNot accepted

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

Full registry 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.

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

Arterial stiffnessAt baseline and at the time of annual follow-up

Assessed by carotid-femoral pulse wave velocity

Endothelial function of the brachial arteryAt baseline and at the time of annual follow-up

Evaluated using flow-mediated dilation measured by ultrasound

Retinal vessel diameterAt baseline and at the time of annual follow-up

Assessed by static retinal vessel analysis

Retinal vessel fractal dimension and tortuosityAt baseline and at the time of annual follow-up

Assessed by static retinal vessel analysis

Study locations

3 locations were listed when this page was built. The first 40 are shown.

Semmelweis University, Department of Surgery, Transplantation and Gastroenterology🇭🇺 Budapest, Hungary

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Semmelweis University, Institute of Preventive Medicine and Public Health🇭🇺 Budapest, Hungary

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Semmelweis University, Pediatric Center🇭🇺 Budapest, Hungary

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