Cardiovascular Risk in Children With Chronic Conditions Study

NCT ID: NCT07086989

Last Updated: 2025-08-08

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-01

Study Completion Date

2029-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Semmelweis University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Kiss Tamás

Principal Investigator

Responsibility Role 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

Site Status NOT_YET_RECRUITING

Semmelweis University, Pediatric Center

Budapest, , Hungary

Site Status RECRUITING

Semmelweis University, Institute of Preventive Medicine and Public Health

Budapest, , Hungary

Site Status ACTIVE_NOT_RECRUITING

Countries

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Hungary

Central Contacts

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Tamas Kiss, MD, PhD

Role: CONTACT

+36202478885

Bálint Mikes, MD, PhD

Role: CONTACT

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.

Reference Type BACKGROUND
PMID: 37491406 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36029824 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34987194 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30798614 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35373933 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34497402 (View on PubMed)

Other Identifiers

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NNGYK/00994-4/2025

Identifier Type: -

Identifier Source: org_study_id

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