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New biomarker study aims to improve outcomes for infants with rare heart condition

NCT ID NCT03404258

Knowledge-focused Sponsor: University of Colorado, Denver 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study measures certain substances in the blood (biomarkers) of infants with a rare heart defect called single-ventricle. The goal is to understand how these biomarkers relate to lung blood flow before and after a specific heart surgery (superior cavo-pulmonary anastomosis). Researchers will compare results from healthy infants and those with the condition to find new ways to predict and treat complications. About 50 infants up to 2 years old will participate.

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.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2018

Expected to finish

Dec 2027

An estimate. End dates often move.

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.

Who is studied

Infants with single ventricle heart disease undergoing trans-catheter evaluation in anticipation of superior cavo-pulmonary anastomosis.

Ages

1 month to 2 years

Sex

Anyone

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: * Congenital heart disease patients undergoing catheterization for pre-SPCA evaluation or undergoing SCPA without plans for cardiac catheterization (utilizing data from a previously performed clinical catheterization). * All patients will have age from 31 days to 2 years. Exclusion Criteria: * Patients who will remain post-op with a pulsatile source of pulmonary blood flow in addition to the cavo-pulmonary anastomosis (so called "1.5 ventricle" repair) will be excluded. * Due to limitations in acceptable sample blood volumes for research, patients with weight \<4kg will be excluded. * Patients will not be excluded on the basis of gender, ethnicity, genetic diagnosis, gestational age at birth, non-cardiac comorbidity, or pre-operative medication regimen.

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Conditions

The condition(s) this trial relates to.

metabolic disease univentricular cardiopathy univentricular heart

As listed by the trial registrant

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

Endothelin Metabolomics Pulmonary vascular resistance abnormality Single-ventricle Superior cavo-pulmonary anastomosis

Contacts and locations

Locations

  • Children's Hospital Colorado

    Denver, Colorado, 80045, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.