Improving Care for Children With Congenital Heart Disease.

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Brief Title

Improving Care for Children With Congenital Heart Disease.

Official Title

Improving Care for Children With Congenital Heart Disease by Cardiovascular Biomarker Profiling and Advanced Non-invasive Cardiac Imaging Techniques.

Brief 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 selected types of with congenital heart disease.
    

Detailed Description

      Analyzing 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
      remodeling 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 standard electrocardiogram (ECG),
      echocardiography and blood sampling to evaluate the heart's anatomy and function and to
      obtain samples for subsequent biomarker analyses.

      Additionally, saliva will 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 will be followed up according to standard care protocols in designated
      paediatric cardiology clinics throughout the participating healthcare regions in Sweden.

      Cases of congenital heart disease that lead to pulmonary over-circulation, such as atrial and
      ventricular septal defects, partial anomalous pulmonary venous drainage, aort-pulmonary
      windows and patent ductus arterious, 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 these 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.
    


Study Type

Interventional


Primary Outcome

Days from diagnosis to open-heart surgery or cardiac catheter intervention in predefined congenital heart disease lesions

Secondary Outcome

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

Condition

Heart Disease Congenital

Intervention

Biomarker analysis at enrolment

Study Arms / Comparison Groups

 Control subjects
Description:  Infants and Children with no evidence of congenital heart disease based on echocardiography and standard ECG assessment

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

98

Start Date

February 17, 2020

Completion Date

October 2024

Primary Completion Date

October 2024

Eligibility Criteria

        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: one of the following congenital heart lesions prior to open heart surgery or
             cardiac catheter intervention: ventricular septal defect, atrial septal defect, patent
             ductus arteriosus, partial anomalous pulmonary venous drainage, aortopulmonary window.

        Exclusion Criteria:

          -  inability to obtain written informed consent prior to study enrolment

          -  non-resident in participating healthcare regions of Sweden during study

          -  age more than 17 years at enrolment

          -  presence of congenital heart disease where one of the above lesions is part of a more
             complex lesion or where the lesion has been treated by open heart surgery or cardiac
             catheter intervention

          -  participation in other research study with conflicting aims / interests
      

Gender

All

Ages

N/A - 17 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Henning Clausen, MD, , 

Location Countries

Sweden

Location Countries

Sweden

Administrative Informations


NCT ID

NCT04667455

Organization ID

2019-05490


Responsible Party

Sponsor

Study Sponsor

Lund University Hospital

Collaborators

 Region Jönköping County

Study Sponsor

Henning Clausen, MD, Principal Investigator, Children's Heart Centre, University Hospital of Lund


Verification Date

September 2020