AzTrials
AzTrials

Kidney TransplantCR3CNCT07086989

Cardiovascular Risk in Children With Chronic Conditions Study

An observational study of Kidney Transplant and Familial Hypercholesterolaemia, run by Semmelweis University at 3 sites in Hungary.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 25 years
How many people
300 participants
Where
3 sitesHungary
Study dates
1 Apr 2025to 31 Jan 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Tamas Kiss, MD, PhD contact

+36202478885

kiss.tamas1@semmelweis.hu

Bálint Mikes, MD, PhD contact

mikes.balint1@semmelweis.hu

Hungary3 sites, 2 recruiting

  • Semmelweis University, Department of Surgery, Transplantation and Gastroenterology

    Budapest, 1082

    Not yet recruiting

  • Semmelweis University, Pediatric Center

    Budapest, 1083

    Recruiting

  • Semmelweis University, Institute of Preventive Medicine and Public Health

    Budapest, 1089

    Active, not recruiting

Other trials in Hungary

About this 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.

Keywords
cardiovascular risk, vasculature, children with chronic conditions
Medical subject headings
Hyperlipoproteinemia Type II, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic, Mucocutaneous Lymph Node Syndrome, Obesity, Overweight, Hypertension

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Arterial stiffness

    Assessed by carotid-femoral pulse wave velocity

    Measured: 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

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

  3. Retinal vessel diameter

    Assessed by static retinal vessel analysis

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

  4. Retinal vessel fractal dimension and tortuosity

    Assessed by static retinal vessel analysis

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

Secondary outcomes (2)

  1. Endothelial function in capillaries

    Assessed by flow-mediated dilation using laser speckle contrast imaging

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

  2. Retinal neurovascular coupling

    Assessed by dynamic retinal vessel analysis

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2025
  2. Study start1 Apr 2025
  3. Primary completion31 Jan 2029 (estimated)
  4. Study completion31 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07086989
Sponsor's protocol ID
NNGYK/00994-4/2025
Acronym
CR3C
Status last verified
Aug 2025
First submitted
17 Jul 2025
Last updated
8 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Transplant and Familial Hypercholesterolaemia, run by Semmelweis University at 3 sites in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tamas Kiss, MD, PhD (+36202478885, kiss.tamas1@semmelweis.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arterial stiffness (time frame: At baseline and at the time of annual follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07086989, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.

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