IBD (general)Recruiting

Cardiovascular Risk in Children With Chronic Conditions Study

Observational · No treatment assigned · 3 sites · Semmelweis University

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

Condition(s) listed: Kidney Transplant, Familial Hypercholesterolaemia and Type 1 Diabetes Mellitus (T1DM). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.

Who can join

Ages 6 to 25
Any sex

Some of the main requirements, copied from the record:

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.

Plus 1 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 300 participants are expected to take part.
Start date: 2025-04-01.
Main results expected around 2029-01-31 (estimate from the record).
3 study sites listed (1 marked recruiting) in Hungary.

Main thing being measured

Arterial stiffness (At baseline and at the time of annual follow-up)

In the researchers’ words

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.

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Recruiting
Phase	Observational
Study type	Observational
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
Lead sponsor	Semmelweis University
Enrollment	300 (estimated)
Start date	2025-04-01
Primary completion (est.)	2029-01-31
First posted	2025-07-25
Last updated	2025-08-08
Official title	Cardiovascular Risk in Children With Chronic Conditions Study
ClinicalTrials.gov ID	NCT07086989

Interventions

None listed

Full eligibility criteria (from the record)

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.

Locations (3)

Site	City	Country	Site status
Semmelweis University, Department of Surgery, Transplantation and Gastroenterology	Budapest	Hungary	Not yet recruiting
Semmelweis University, Pediatric Center	Budapest	Hungary	Recruiting
Semmelweis University, Institute of Preventive Medicine and Public Health	Budapest	Hungary	Active, not recruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.