Improving Care for Children With Congenital Heart Disease.

NCT04667455 | Enrolling By Invitation

• 1 other identifier: 2019-05490
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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 in selected types of with congenital heart disease.

Conditions

Heart Disease Congenital; Ventricular Septal Defect; Atrial Septal Defect; Patent Ductus Arteriosus; Partial Anomalous Pulmonary Venous Connection; Aortopulmonary Window; Cardiovascular Diseases

Keywords

congenital heart disease

Outcome Measures

Primary Outcomes (1)

• 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

  3 years

Secondary Outcomes (3)

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

  3 years

• Circulating cardiovascular protein biomarker profiling in infants and children with predefined congenital heart disease lesions vs normal controls using blood samples.

  3 years

• Measurement of cardiac magnetic resonance 4-dimensional flows to estimate 'kinetic energy' supported by advanced echocardiography in normal controls vs predefined lesions of congenital heart disease

  3 years

Study Arms (2)

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

Diagnostic Test: Biomarker analysis at enrolment; Diagnostic Test: Biomarker analyses throughout the study

Interventions

Biomarker analysis at enrolment DIAGNOSTIC_TEST

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

Also known as: blood-based and non-invasive cardiac imaging modalities at enrolment

Congenital heart disease subjects

Biomarker analyses throughout the study DIAGNOSTIC_TEST

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

Also known as: blood-based and non-invasive cardiac imaging modalities throughout the study

Congenital heart disease subjects

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lund University Hospital: lead
• Region Jönköping County: collaborator
• Göteborg University: collaborator

Study Sites (1)

Children's Heart Centre at Lund's University Hospital

Lund, Skåne County, 221 85, Sweden

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Heart Septal Defects, Ventricular; Heart Septal Defects, Atrial; Ductus Arteriosus, Patent; Aortopulmonary Septal Defect; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Septal Defects

Study Officials

• Henning Clausen, MD

  Children's Heart Centre, University Hospital of Lund

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participant and standard clinical care providers will be blinded to biomarker analyses and advanced cardiac imaging findings throughout the study
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hennnig Clausen, MD

Model Details: case-control cohort

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: December 14, 2020
• Study Start: February 17, 2020
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: December 2024
• Access Criteria: After conclusion of the study, anonymised clinical data may be may available after reasonable request to medical researcher in recognised non-profit academic institutions

Locations

SE (1)