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Improving Care for Children With Congenital Heart Disease.

NCT04667455 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 313

Last updated 2026-05-08

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Biomarker analysis 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

DIAGNOSTIC_TEST

Biomarker analyses 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

Sponsors & Collaborators

  • Region Jönköping County

    collaborator OTHER_GOV

  • Göteborg University

    collaborator OTHER

  • Lund University Hospital

    lead OTHER

Principal Investigators

  • Henning Clausen, MD · Children's Heart Centre, University Hospital of Lund

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-17
Primary Completion
2026-05-04
Completion
2026-05-04

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04667455 on ClinicalTrials.gov