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NCT Number: NCT07086989

Cardiovascular Risk in Children With Chronic Conditions Study

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.

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Key information

Conditions

Kidney Transplant Aorta Stenosis Aortic Coarctation Aortic Valve Disease Aortic Valve Stenosis Autoimmune Diseases Blood-Borne Infections Body Weight Bone Marrow Transplant Cancer (Solid Tumors) Cardiovascular Abnormalities Cardiovascular Diseases Chronic Disease Chronic Kidney Disease Coarctation of Aorta Communicable Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Digestive System Diseases Disease Attributes Dyslipaemia Dyslipidemias Endocrine System Diseases Familial Hypercholesterolaemia Fatty Liver Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Genetic Diseases, Inborn Genital Diseases Glucose Metabolism Disorders HIV Infection HIV Infections Heart Defects, Congenital Heart Diseases Heart Valve Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Hypertension Hypertension, Pulmonary Immune System Diseases Immunologic Deficiency Syndromes Immunoproliferative Disorders Infections Inflammatory Bowel Disease (IBD) Inflammatory Bowel Diseases Intestinal Diseases Juvenile Idiopahtic Arthritis Kawasaki Disease Kidney Diseases Lentivirus Infections Leukemia Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Lipoprotein(a) Liver Diseases Liver Transplant Lung Diseases Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Male Urogenital Diseases Metabolic Diseases Metabolism, Inborn Errors Mucocutaneous Lymph Node Syndrome Neoplasms Neoplasms by Histologic Type Non Alcoholic Fatty Liver Disease Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity and Overweight Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Hypertension RNA Virus Infections Renal Insufficiency Renal Insufficiency, Chronic Respiratory Tract Diseases Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Systemic Lupus Erthematosus Transposition of Great Arteries Transposition of Great Vessels Type 1 Diabetes Mellitus (T1DM) Type 2 Diabetes Mellitus (T2DM) Urogenital Diseases Urologic Diseases Vascular Diseases Vasculitis Ventricular Outflow Obstruction Virus Diseases White Coat Hypertension

Age range

6 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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

  • Severe intellectual and developmental disability;
  • Decompensated heart failure;
  • Severe primary immunodeficiency;
  • Ongoing intravenous chemotherapy;
  • Infectious diseases posing a public health risk; or
  • History of regular alcohol or drug use.

Treatment and study plan

Primary outcomes

  1. Arterial stiffness

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

    Assessed by carotid-femoral pulse wave velocity

  2. Endothelial function of the brachial artery

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

    Evaluated using flow-mediated dilation measured by ultrasound

  3. Retinal vessel diameter

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

    Assessed by static retinal vessel analysis

  4. Retinal vessel fractal dimension and tortuosity

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

    Assessed by static retinal vessel analysis

Secondary outcomes

  1. Endothelial function in capillaries

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

    Assessed by flow-mediated dilation using laser speckle contrast imaging

  2. Retinal neurovascular coupling

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

    Assessed by dynamic retinal vessel analysis

Study contacts

Contact information is provided by the study sponsor or research team.

Bálint Mikes, MD, PhD

CONTACT

[email protected]

Tamas Kiss, MD, PhD

CONTACT

[email protected]

+36202478885

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Acronym: CR3C

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jul 25, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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