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Cardiovascular Risk in Children With Chronic Conditions Study (CR3C)

S

Semmelweis University

Status

Enrolling

Conditions

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

Study type

Observational

Funder types

Other

Identifiers

NCT07086989
NNGYK/00994-4/2025

Details and patient eligibility

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.

Enrollment

300 estimated patients

Sex

All

Ages

6 to 25 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

3

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Central trial contact

Bálint Mikes, MD, PhD; Tamas Kiss, MD, PhD

Data sourced from clinicaltrials.gov

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