Copenhagen Baby Heart Study - Impact
Run by Copenhagen University Hospital, Rigshospitalet · NCT05838079 · Data updated 2026-11-12
This study looks at how common undetected heart problems are in newborns and their effects during early childhood, while also checking heart health in Danish kids.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Day to 99 Years |
| Sex | All |
| Enrollment | 35000 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Locations | 3 sites (Copenhagen Ø and 2 other locations) |
| Status | Recruiting |
| Started | November 1, 2018 |
| Main results expected | July 2029 |
| Study ends | July 2029 |
| Registry record updated | May 1, 2023 |
| Trial ID | NCT05838079 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include newborns who participated in the original Copenhagen Baby Heart study or their family members, as well as children born to mothers with pre-existing or gestational diabetes.
✕Probably not a fit
Patients who do not have a connection to the original study or do not meet the specific inclusion criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The Copenhagen Baby Heart Study - Impact (CBHS-I) is an observational study that extends the previous Copenhagen Baby Heart study, which involved over 25,000 newborns in the Copenhagen area. This study aims to assess the prevalence of congenital and inherited heart diseases that were not detected prenatally and to evaluate their consequences during early childhood. Participants will undergo clinical examinations, including echocardiography and electrocardiography, to establish reference values for these tests in Danish children. Additionally, the study will explore associations between various prenatal and postnatal factors and the risk of congenital heart disease.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and management of congenital heart diseases in children.
How similar studies have gone: Other studies focusing on congenital heart disease have shown success in identifying risk factors and improving outcomes, making this approach promising.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant in CBH or * Family member of a participant in CBH or * Born to mothers with pre-existing or gestational diabetes at either Rigshospitalet, Hvidovre Hospital, or Herlev Hospital during the period July 2020 through December 2023. Exclusion Criteria: * Faliure of providing concent (parents)
Where it's running
-
Rigshospitalet Copenhagen University Hospital.
Copenhagen Ø, Denmark Recruiting -
Herlev and Gentofte Hospital
Herlev, Denmark Recruiting -
Hvidovre Hospital
Hvidovre, Denmark Recruiting
Study contacts
- Principal investigator: Henning Bundgaard, MD, DMSc — Department of Cardiology, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Denmark
- Study coordinator: Henning Bundgaard, MD, DMSc
- Email: henning.bundgaard@regionh.dk
- Phone: +4535450512
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.