Heart Disease CongenitalNCT04667455
Improving Care for Children With Congenital Heart Disease.
A study testing Biomarker analysis at enrolment and Biomarker analyses throughout the study in people with Heart Disease Congenital and Ventricular Septal Defect, run by Lund University Hospital at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Disease Congenital, Ventricular Septal Defect, Atrial Septal Defect
- What is being tested?
- Biomarker analysis at enrolment and Biomarker analyses throughout the study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 313 participants
- Where
- 1 siteSweden
- Study dates
- 17 Feb 2020to 4 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Children's Heart Centre at Lund's University Hospital
Lund, Skåne County, 221 85
About this study
Official title: Improving Care for Children With Congenital Heart Disease by Cardiovascular Biomarker Profiling and Advanced Non-invasive Cardiac Imaging Techniques.
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.
Read the detailed description
Analysing circulating cardiovascular biomarkers using blood samples should improve identification of congenital heart disease in newborns, in particular for those needing future cardiac interventions.
Comparing such biomarker profiles and non-invasive cardiac imaging results over time in infants and children should lead to better understanding of the complex cardiovascular remodelling processes in common congenital heart lesions, such as atrial or ventricular septal defects. This in turn should lead to an improved risk factor assessment model to guide treatment decisions in children with congenital heart disease in the foreseeable future.
To test our hypothesis, that cardiovascular biomarker profiling and non-invasive cardiac imaging findings in infants and children with congenital heart disease, differs from healthy controls, we will assess controls at enrolment and follow cases with predefined congenital heart disease lesions over a maximum of three years or up till one year after open heart surgery / cardiac catheter intervention to correct such lesions.
Infants and children resident in designated healthcare regions of Sweden will be invited to participate after study advertisement. Written informed consent will be obtained from legal guardians and assent will be sought from children who can communicate verbally with the dedicated paediatric research team.
Healthy subjects 0-17 years at enrolment will undergo i.e. standard electrocardiogram (ECG), echocardiography and blood sampling to evaluate the heart's anatomy and function and to obtain samples for subsequent blood-based biomarker analyses.
Additionally, saliva may be sampled and/or neonatal blood samples from national biobank storage will be retrieved for comparison with cardiovascular biomarker profiles in these controls if available.
To evaluate these cardiovascular assessments in predefined age groups, a subgroup of these participating subjects will be asked to complete additional cardiac magnetic resonance imaging based on study protocols.
Incidental findings of congenital heart disease will be followed up according to standard care protocols in designated paediatric cardiology clinics throughout the participating healthcare regions in Sweden.
A subgroup of cases with congenital heart disease that lead to pulmonary over-circulation, such as atrial and ventricular septal defects, partial anomalous pulmonary venous drainage, aorto-pulmonary windows and patent ductus arteriosus, will be asked to participate if the lesion has not been treated by open heart surgery or cardiac catheter interventions at enrolment.
Subjects with these predefined types of congenital heart disease aged 0-17 years at enrolment will undergo standard electrocardiograms (ECG), echocardiography and blood sampling to assess biomarkers at baseline and at 6-12 month follow-up intervals in dedicated paediatric cardiology clinics over a maximum period of three years.
Saliva samples and/or cardiovascular tissue obtained during open heart surgery may also be analysed for studied cardiovascular biomarkers. Additionally, neonatal blood samples from national biobank storage will be retrieved for comparison with current biomarker profiles if available.
For those congenital heart disease cases referred for open heart surgery or cardiac catheter intervention to correct the congenital heart lesion based on standard care assessment decisions during the study period, follow-up will end one year after such intervention. To evaluate cardiovascular assessments in predefined age groups, a subgroup of participating cases will be asked to complete additional cardiac magnetic resonance imaging based on study protocols.
Prospective evaluation of developed blood-based biomarkers assays and novel cardiac imaging biomarkers of heart function in infants and children will be further assessed to evaluate the feasibility of these methods to timely and precisely identify newborns with congenital heart disease by combined blood-based biomarker analyses and to assess whether newly identified functional parameters on heart function would be suitable to guide clinical risk-assessment and decision-making processes in terms of type and timing of cardiac interventions . These imaging biomarkers will, for example, evaluate the usefulness of measuring kinetic energy within the left ventricle of the heart in children with congenital heart disease based on magnetic resonance and echocardiography methods.
- Conditions
- Heart Disease Congenital, Ventricular Septal Defect, Atrial Septal Defect, Patent Ductus Arteriosus, Partial Anomalous Pulmonary Venous Connection, Aortopulmonary Window
- Being tested
- Biomarker analysis at enrolment, Biomarker analyses throughout the study
- Keywords
- congenital heart disease
- Medical subject headings
- Heart Defects, Congenital, Heart Septal Defects, Ventricular, Heart Septal Defects, Atrial, Ductus Arteriosus, Patent, Aortopulmonary Septal Defect, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker analysis at enrolmentDiagnostic test
Also called blood-based and non-invasive cardiac imaging modalities at enrolment
Controls will be compared to cases using blood-based biomarker analyses and non-invasive cardiac imaging techniques to improve early diagnosis and risk stratification of cases
Biomarker analyses throughout the studyDiagnostic test
Also called blood-based and non-invasive cardiac imaging modalities throughout the study
Controls will be compared to cases using blood-based biomarker analyses and non-invasive cardiac imaging techniques to improve early diagnosis and risk stratification of cases
| Study group | Role | What they receive |
|---|---|---|
| Control subjects | No intervention | Infants and Children with no evidence of congenital heart disease based on clinical examination and echocardiography / standard ECG assessment where necessary. |
| Congenital heart disease subjects | Active comparator | Infants and Children with evidence of predefined congenital heart disease lesions based on clinical examination, echocardiography and standard ECG assessment Receives: Diagnostic Test: Biomarker analysis at enrolment; Diagnostic Test: Biomarker analyses throughout the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening for congenital heart disease in newborns using circulating biomarkers in blood samples
Results will be based on circulating biomarker analysis in infants using dried blood spot samples to improve detection of congenital heart disease. Results in normal controls will be compared to predefined congenital heart disease lesions and results expressed in ng/l using cardiovascular biomarkers such as NT-proBNP and IL1RL1 (ST2).
Measured: 3 years
Secondary outcomes (3)
Circulating cardiovascular protein biomarker profiling in infants and children with predefined congenital heart disease lesions vs normal controls using blood samples.
Circulating biomarker profiling results will be expressed in 'NPX' units (Normalized Protein eXpression concentrations from proximity extension assay analyses of protein concentrations in blood samples using O-link's 'Target 96 cardiovascular III' panel, link: https://www.olink.com/products/cvd-iii-panel/)
Measured: 3 years
Measurement of cardiac magnetic resonance 4-dimensional flows to estimate e.g. 'kinetic energy' supported by advanced echocardiography in normal controls vs predefined lesions of congenital heart disease
Results will be based on cardiac magnetic resonance 4D flow and supported by advanced echocardiographic assessments and expressed as kinetic energy (milli Joule) to assess for normal and abnormal patterns of cardiac function.
Measured: 3 years
Time from diagnosis to open-heart surgery or cardiac catheter intervention in predefined congenital heart disease lesions
Number of days from date of diagnosis of predefined congenital heart disease lesion until date of open-heart surgery or cardiac catheter intervention to treat lesion
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start17 Feb 2020
- Primary completion4 May 2026
- Study completion4 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Disease CongenitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- case-control cohort
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region Jönköping County, Göteborg University
- Responsible party
- Principal investigator, Henning Clausen, MD, Lund University Hospital
- Investigators
- Henning Clausen, MD, Principal investigator, Children's Heart Centre, University Hospital of Lund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667455
- Sponsor's protocol ID
- 2019-05490
- Other IDs
- 2019
- Status last verified
- May 2026
- First submitted
- 26 Oct 2020
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised clinical data relevant to the publication process of peer-reviewed scientific journals may be made available on request.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Care for Children With Congenital Heart Disease by Cardiovascular Biomarker Profiling and Advanced Non-invasive Cardiac Imaging Techniques.
- ClinicalTrials.gov ID
- NCT04667455
- Acronym / sponsor ID
- 2019-05490
- Conditions
- Heart Disease Congenital, Ventricular Septal Defect, Atrial Septal Defect, Patent Ductus Arteriosus, Partial Anomalous Pulmonary Venous Connection, Aortopulmonary Window
- Keywords
- congenital heart disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Collaborators
- Region Jönköping County, Göteborg University
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 4 May 2026 (actual)
- Study completion
- 4 May 2026 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Analysing circulating cardiovascular biomarkers using blood samples should improve identification of congenital heart disease in newborns, in particular for those needing future cardiac interventions.
Comparing such biomarker profiles and non-invasive cardiac imaging results over time in infants and children should lead to better understanding of the complex cardiovascular remodelling processes in common congenital heart lesions, such as atrial or ventricular septal defects. This in turn should lead to an improved risk factor assessment model to guide treatment decisions in children with congenital heart disease in the foreseeable future.
To test our hypothesis, that cardiovascular biomarker profiling and non-invasive cardiac imaging findings in infants and children with congenital heart disease, differs from healthy controls, we will assess controls at enrolment and follow cases with predefined congenital heart disease lesions over a maximum of three years or up till one year after open heart surgery / cardiac catheter intervention to correct such lesions.
Infants and children resident in designated healthcare regions of Sweden will be invited to participate after study advertisement. Written informed consent will be obtained from legal guardians and assent will be sought from children who can communicate verbally with the dedicated paediatric research team.
Healthy subjects 0-17 years at enrolment will undergo i.e. standard electrocardiogram (ECG), echocardiography and blood sampling to evaluate the heart's anatomy and function and to obtain samples for subsequent blood-based biomarker analyses.
Additionally, saliva may be sampled and/or neonatal blood samples from national biobank storage will be retrieved for comparison with cardiovascular biomarker profiles in these controls if available.
To evaluate these cardiovascular assessments in predefined age groups, a subgroup of these participating subjects will be asked to complete additional cardiac magnetic resonance imaging based on study protocols.
Incidental findings of congenital heart disease will be followed up according to standard care protocols in designated paediatric cardiology clinics throughout the participating healthcare regions in Sweden.
A subgroup of cases with congenital heart disease that lead to pulmonary over-circulation, such as atrial and ventricular septal defects, partial anomalous pulmonary venous drainage, aorto-pulmonary windows and patent ductus arteriosus, will be asked to participate if the lesion has not been treated by open heart surgery or cardiac catheter interventions at enrolment.
Subjects with these predefined types of congenital heart disease aged 0-17 years at enrolment will undergo standard electrocardiograms (ECG), echocardiography and blood sampling to assess biomarkers at baseline and at 6-12 month follow-up intervals in dedicated paediatric cardiology clinics over a maximum period of three years.
Saliva samples and/or cardiovascular tissue obtained during open heart surgery may also be analysed for studied cardiovascular biomarkers. Additionally, neonatal blood samples from national biobank storage will be retrieved for comparison with current biomarker profiles if available.
For those congenital heart disease cases referred for open heart surgery or cardiac catheter intervention to correct the congenital heart lesion based on standard care assessment decisions during the study period, follow-up will end one year after such intervention. To evaluate cardiovascular assessments in predefined age groups, a subgroup of participating cases will be asked to complete additional cardiac magnetic resonance imaging based on study protocols.
Prospective evaluation of developed blood-based biomarkers assays and novel cardiac imaging biomarkers of heart function in infants and children will be further assessed to evaluate the feasibility of these methods to timely and precisely identify newborns with congenital heart disease by combined blood-based biomarker analyses and to assess whether newly identified functional parameters on heart function would be suitable to guide clinical risk-assessment and decision-making processes in terms of type and timing of cardiac interventions . These imaging biomarkers will, for example, evaluate the usefulness of measuring kinetic energy within the left ventricle of the heart in children with congenital heart disease based on magnetic resonance and echocardiography methods.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- case-control cohort
| Arm | Type | Receives |
|---|---|---|
| Control subjects | No intervention | –Infants and Children with no evidence of congenital heart disease based on clinical examination and echocardiography / standard ECG assessment where necessary. |
| Congenital heart disease subjects | Active comparator | Diagnostic Test: Biomarker analysis at enrolment, Diagnostic Test: Biomarker analyses throughout the studyInfants and Children with evidence of predefined congenital heart disease lesions based on clinical examination, echocardiography and standard ECG assessment |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarker analysis at enrolmentAlso: blood-based and non-invasive cardiac imaging modalities at enrolmentControls will be compared to cases using blood-based biomarker analyses and non-invasive cardiac imaging techniques to improve early diagnosis and risk stratification of cases | Diagnostic test | Congenital heart disease subjects |
| Biomarker analyses throughout the studyAlso: blood-based and non-invasive cardiac imaging modalities throughout the studyControls will be compared to cases using blood-based biomarker analyses and non-invasive cardiac imaging techniques to improve early diagnosis and risk stratification of cases | Diagnostic test | Congenital heart disease subjects |
Primary outcome
Screening for congenital heart disease in newborns using circulating biomarkers in blood samples
Time frame: 3 years
Results will be based on circulating biomarker analysis in infants using dried blood spot samples to improve detection of congenital heart disease. Results in normal controls will be compared to predefined congenital heart disease lesions and results expressed in ng/l using cardiovascular biomarkers such as NT-proBNP and IL1RL1 (ST2).
3 secondary outcomes
Circulating cardiovascular protein biomarker profiling in infants and children with predefined congenital heart disease lesions vs normal controls using blood samples.
Time frame: 3 years
Measurement of cardiac magnetic resonance 4-dimensional flows to estimate e.g. 'kinetic energy' supported by advanced echocardiography in normal controls vs predefined lesions of congenital heart disease
Time frame: 3 years
Time from diagnosis to open-heart surgery or cardiac catheter intervention in predefined congenital heart disease lesions
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- publication (open access)Link provided by the sponsor.
- publication (open access)Link provided by the sponsor.
- publication (open access)Link provided by the sponsor.
- publication (open access)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymised clinical data relevant to the publication process of peer-reviewed scientific journals may be made available on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henning Clausen, MD principal investigator
Children's Heart Centre, University Hospital of Lund
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biomarker analysis at enrolment and Biomarker analyses throughout the study in people with Heart Disease Congenital and Ventricular Septal Defect, run by Lund University Hospital at 1 site in Sweden.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening for congenital heart disease in newborns using circulating biomarkers in blood samples (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2026.