Cardiovascular Risk in Children With Chronic Conditions Study

NCT07086989 | Recruiting

• 1 other identifier: NNGYK/00994-4/2025
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

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.

Conditions

Kidney 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

Keywords

cardiovascular risk; vasculature; children with chronic conditions

Outcome Measures

Primary Outcomes (4)

• Arterial stiffness

  Assessed by carotid-femoral pulse wave velocity

  At baseline and at the time of annual follow-up

• Endothelial function of the brachial artery

  Evaluated using flow-mediated dilation measured by ultrasound

  At baseline and at the time of annual follow-up

• Retinal vessel diameter

  Assessed by static retinal vessel analysis

  At baseline and at the time of annual follow-up

• Retinal vessel fractal dimension and tortuosity

  Assessed by static retinal vessel analysis

  At baseline and at the time of annual follow-up

Secondary Outcomes (2)

• Endothelial function in capillaries

  At baseline and at the time of annual follow-up

• Retinal neurovascular coupling

  At baseline and at the time of annual follow-up

Eligibility Criteria

• Age: 6 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (3)

Semmelweis University, Department of Surgery, Transplantation and Gastroenterology

Budapest, 1082, Hungary

NOT YET RECRUITING

Semmelweis University, Pediatric Center

Budapest, 1083, Hungary

RECRUITING

Semmelweis University, Institute of Preventive Medicine and Public Health

Budapest, 1089, Hungary

ACTIVE NOT RECRUITING

Related Publications (6)

• Hanssen H, Moholdt T, Bahls M, Biffi A, Siegrist M, Lewandowski AJ, Biondi-Zoccai G, Cavarretta E, Kokkvoll A, Lochen ML, Maestrini V, Pinto RS, Palermi S, Thivel D, Wojcik M, Hansen D, Van Craenenbroeck EM, Weghuber D, Kraenkel N, Tiberi M. Lifestyle interventions to change trajectories of obesity-related cardiovascular risk from childhood onset to manifestation in adulthood: a joint scientific statement of the task force for childhood health of the European Association of Preventive Cardiology and the European Childhood Obesity Group. Eur J Prev Cardiol. 2023 Oct 10;30(14):1462-1472. doi: 10.1093/eurjpc/zwad152.

  PMID: 37491406 BACKGROUND

• Varley BJ, Nasir RF, Skilton MR, Craig ME, Gow ML. Early Life Determinants of Vascular Structure in Fetuses, Infants, Children, and Adolescents: A Systematic Review and Meta-Analysis. J Pediatr. 2023 Jan;252:101-110.e9. doi: 10.1016/j.jpeds.2022.08.033. Epub 2022 Aug 24.

  PMID: 36029824 BACKGROUND

• Raitakari O, Pahkala K, Magnussen CG. Prevention of atherosclerosis from childhood. Nat Rev Cardiol. 2022 Aug;19(8):543-554. doi: 10.1038/s41569-021-00647-9. Epub 2022 Jan 5.

  PMID: 34987194 BACKGROUND

• de Ferranti SD, Steinberger J, Ameduri R, Baker A, Gooding H, Kelly AS, Mietus-Snyder M, Mitsnefes MM, Peterson AL, St-Pierre J, Urbina EM, Zachariah JP, Zaidi AN. Cardiovascular Risk Reduction in High-Risk Pediatric Patients: A Scientific Statement From the American Heart Association. Circulation. 2019 Mar 26;139(13):e603-e634. doi: 10.1161/CIR.0000000000000618.

  PMID: 30798614 BACKGROUND

• Jacobs DR Jr, Woo JG, Sinaiko AR, Daniels SR, Ikonen J, Juonala M, Kartiosuo N, Lehtimaki T, Magnussen CG, Viikari JSA, Zhang N, Bazzano LA, Burns TL, Prineas RJ, Steinberger J, Urbina EM, Venn AJ, Raitakari OT, Dwyer T. Childhood Cardiovascular Risk Factors and Adult Cardiovascular Events. N Engl J Med. 2022 May 19;386(20):1877-1888. doi: 10.1056/NEJMoa2109191. Epub 2022 Apr 4.

  PMID: 35373933 BACKGROUND

• Townsend N, Kazakiewicz D, Lucy Wright F, Timmis A, Huculeci R, Torbica A, Gale CP, Achenbach S, Weidinger F, Vardas P. Epidemiology of cardiovascular disease in Europe. Nat Rev Cardiol. 2022 Feb;19(2):133-143. doi: 10.1038/s41569-021-00607-3. Epub 2021 Sep 8.

  PMID: 34497402 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum and blood plasma

MeSH Terms

Conditions

Hyperlipoproteinemia Type II; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic; Mucocutaneous Lymph Node Syndrome; Obesity; Overweight; Hypertension; Aortic Coarctation; Neoplasms; Leukemia; Lymphoma; Aortic Valve Stenosis; Non-alcoholic Fatty Liver Disease; White Coat Hypertension; Hypertension, Pulmonary; Inflammatory Bowel Diseases; HIV Infections; Transposition of Great Vessels

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Fatty Liver; Liver Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Gastroenteritis; Gastrointestinal Diseases; Intestinal Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Immunologic Deficiency Syndromes

Study Officials

• Tamas Kiss, MD, PhD

  Semmelweis University, Pediatric Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamas Kiss, MD, PhD

CONTACT

+36202478885; kiss.tamas1@semmelweis.hu

Bálint Mikes, MD, PhD

CONTACT

mikes.balint1@semmelweis.hu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 25, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

HU (3)