| NCT ID | NCT05838079 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Henning Bundgaard |
| Condition | Congenital Heart Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 35,000 participants |
| Start Date | 2018-11-01 |
| Primary Completion | 2029-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 35,000 participants in total. It began in 2018-11-01 with a primary completion date of 2029-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Copenhagen Baby Heart Study - Impact (CBHS-I) is an extension to Copenhagen Baby Heart (CBH) which included over 25.000 new-borns in the Copenhagen area between 2016-2018. Based on clinical and subclinical deviations in the examinations in CBH, subgroups of participants will be invited to clinical examinations (echocardiography and electrocardiogram) in early childhood. There will also be a new, targeted inclusion based on certain exposures during pregnancy. The main objectives are to assess the prevalence of congenital and inherited heart disease and, and the development of these during early childhood; examining the association between pre- and postnatal exposure, disease, lifestyle, environmental and genetic factors; continue to establish reference values for echocardiography in Danish neonates and children.
Eligibility 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)
Contact & Investigator
Henning Bundgaard, MD, DMSc
PRINCIPAL INVESTIGATOR
Department of Cardiology, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Denmark
Frequently Asked Questions
Who can join the NCT05838079 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 99 Years, studying Congenital Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05838079 currently recruiting?
Yes, NCT05838079 is actively recruiting participants. Contact the research team at henning.bundgaard@regionh.dk for enrollment information.
Where is the NCT05838079 trial being conducted?
This trial is being conducted at Copenhagen Ø, Denmark, Herlev, Denmark, Hvidovre, Denmark.
Who is sponsoring the NCT05838079 clinical trial?
NCT05838079 is sponsored by Henning Bundgaard. The principal investigator is Henning Bundgaard, MD, DMSc at Department of Cardiology, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Denmark. The trial plans to enroll 35,000 participants.