ClinicalTrials.gg
RecruitingNCT07086989CR3CUpdated Aug 8, 2025

Cardiovascular Risk in Children With Chronic Conditions Study

An observational study in Kidney Transplant, Familial Hypercholesterolaemia and Type 1 Diabetes Mellitus (T1DM), sponsored by Semmelweis University. Recruiting at 3 sites in Hungary. Open to participants aged 6 Years to 25 Years. Per ClinicalTrials.gov, last updated 2025-08-08.

Sponsored by Semmelweis University · Observational

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
6 Years to 25 Years
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Hyperlipoproteinemia Type II

249 studies on the registry are indexed under Hyperlipoproteinemia Type II; 56 are open to participants now.

This study's planned enrollment of 300 is below the median of 770 across 64 observational studies indexed under Hyperlipoproteinemia Type II.

Browse Hyperlipoproteinemia Type II studies →

Lead sponsor

Semmelweis University is the lead sponsor of 140 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Arterial stiffness

    Assessed by carotid-femoral pulse wave velocity

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

  2. Endothelial function of the brachial artery

    Evaluated using flow-mediated dilation measured by ultrasound

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

  3. Retinal vessel diameter

    Assessed by static retinal vessel analysis

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

  4. Retinal vessel fractal dimension and tortuosity

    Assessed by static retinal vessel analysis

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

Secondary outcomes

  1. Endothelial function in capillaries

    Assessed by flow-mediated dilation using laser speckle contrast imaging

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

  2. Retinal neurovascular coupling

    Assessed by dynamic retinal vessel analysis

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

07

Study locations

1 of 3 sites recruiting
  • 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

    Not enrolling at this site.

08

References and documents

Publications

  • 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. PubMed 37491406 ↗
  • 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. PubMed 36029824 ↗
  • 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. PubMed 34987194 ↗
  • 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. PubMed 30798614 ↗
  • 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. PubMed 35373933 ↗
  • 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. PubMed 34497402 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07086989
Responsible party
Dr. Kiss Tamás (Principal Investigator, Semmelweis University) — Principal investigator
First posted
Jul 25, 2025
Start date
Apr 1, 2025
Primary completion
Jan 31, 2029 (estimated)
Completion
Jan 31, 2029 (estimated)
Last update
Aug 8, 2025

Study contacts

Tamas Kiss, MD, PhD
Contact
kiss.tamas1@semmelweis.hu
+36202478885
Bálint Mikes, MD, PhD
Contact
mikes.balint1@semmelweis.hu
Tamas Kiss, MD, PhD
principal investigator · Semmelweis University, Pediatric Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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