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New study aims to spot heart defects in newborns with simple blood test

NCT ID NCT04667455

Diagnosis Sponsor: Lund University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study looked at 313 children to see if blood tests and advanced heart scans could help detect congenital heart disease earlier and predict which children might need surgery. Researchers compared children with heart defects to healthy controls using blood biomarkers and non-invasive imaging. The goal is to improve early diagnosis and risk assessment for these young patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
blood-based biomarker analysis and non-invasive cardiac imaging
What this could lead to
If successful, this could lead to earlier and more accurate detection of congenital heart disease in newborns and better prediction of which children will need surgery.
What could go wrong
This is an observational study, not a treatment trial. The findings may not change current care immediately, and the biomarkers may not be accurate enough for widespread use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

313 people

The number who actually took part.

Started

Feb 2020

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 17 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 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. Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

aortopulmonary window atrial septal defect cardiovascular disorder congenital heart disease congenital partial pulmonary venous return anomaly patent ductus arteriosus ventricular septal defect

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortopulmonary window Atrial septal defect Cardiovascular diseases Heart disease congenital Partial anomalous pulmonary venous connection Patent ductus arteriosus Ventricular septal defect

Contacts and locations

Locations

  • Children's Heart Centre at Lund's University Hospital

    Lund, Skåne County, 221 85, Sweden

More trials for these conditions

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