Cardiovascular Risk in Children With Chronic Conditions Study
NCT ID: NCT07086989
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2025-04-01
2029-01-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
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.
6 Years
25 Years
ALL
No
Sponsors
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Semmelweis University
OTHER
Responsible Party
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Dr. Kiss Tamás
Principal Investigator
Principal Investigators
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Tamas Kiss, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Semmelweis University, Pediatric Center
Locations
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Semmelweis University, Department of Surgery, Transplantation and Gastroenterology
Budapest, , Hungary
Semmelweis University, Pediatric Center
Budapest, , Hungary
Semmelweis University, Institute of Preventive Medicine and Public Health
Budapest, , Hungary
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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NNGYK/00994-4/2025
Identifier Type: -
Identifier Source: org_study_id
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