CompletedNot Applicable

Improving Care for Children With Congenital Heart Disease.

Sweden313 participantsStarted 2020-02-17

Plain-language summary

Establish a cardiovascular biomarker profile to help screening for congenital heart disease in infants and children as well as use non-invasive cardiac imaging in combination with such profiling to better predict the need for future cardiac interventions such as open heart surgery or cardiac catheter intervention in selected types of with congenital heart disease.

Who can participate

Age range

17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * obtained written informed consent prior to enrolment * resident within participating healthcare regions in Sweden during study * age 0-17 years at enrolment * Controls: No evidence of congenital heart disease and no history of cardiovascular disease * Cases: congenital heart lesions prior to open heart surgery or cardiac catheter intervention with grouping into i.e. ventricular septal defects and atrial septal defects, complex and critical cases requiring infant surgery or patency of the arterial duct to maintain the circulation postnatally. Exclusion Criteria: * inability to obtain written informed consent prior to study enrolment and/or comply with study protocol * non-resident in participating healthcare regions of Sweden during study * age more than 17 years at enrolment * presence of congenital heart disease where the lesion has already been treated by open heart surgery or cardiac catheter intervention * participation in other research study with conflicting aims / interests

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Screening for congenital heart disease in newborns using circulating biomarkers in blood samples

Timeframe: 3 years

Trial details

NCT IDNCT04667455

SponsorLund University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-04

View on ClinicalTrials.gov More Heart Disease Congenital trials