Cardiovascular Risk in Children With Chronic Conditions Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-25
SponsorSemmelweis University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals aged between 6 and 25 years;

Diagnosed with a chronic childhood condition/disease associated with an increased risk of early cardiovascular disease;

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.

Disqualifiers

Severe intellectual and developmental disability;

Decompensated heart failure;

Severe primary immunodeficiency;

Ongoing intravenous chemotherapy;

Trial population

Children, adolescents, and young adults (aged 6-25 years) who have been diagnosed with a chronic childhood condition associated with an increased risk of early-onset cardiovascular disease, and who are receiving care at a university-affiliated clinical setting. Participants must be capable of providing informed consent (if ≥18 years old) or have consent provided by a legal guardian (if \<18 years old). The population excludes individuals with severe intellectual disabilities, decompensated heart failure, severe primary immunodeficiencies, active intravenous chemotherapy, communicable diseases that pose a public health risk, or a history of regular alcohol or drug use.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Arterial stiffness

Assessed by carotid-femoral pulse wave velocity

Time frame
At baseline and at the time of annual follow-up
2

Endothelial function of the brachial artery

Evaluated using flow-mediated dilation measured by ultrasound

Time frame
At baseline and at the time of annual follow-up
3

Retinal vessel diameter

Assessed by static retinal vessel analysis

Time frame
At baseline and at the time of annual follow-up
4

Retinal vessel fractal dimension and tortuosity

Assessed by static retinal vessel analysis

Time frame
At baseline and at the time of annual follow-up

Secondary outcomes

1

Endothelial function in capillaries

Assessed by flow-mediated dilation using laser speckle contrast imaging

Time frame
At baseline and at the time of annual follow-up
2

Retinal neurovascular coupling

Assessed by dynamic retinal vessel analysis

Time frame
At baseline and at the time of annual follow-up

Other outcomes

Sponsors and contacts

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