Biomarker Study for Heart Failure in Children With Single Ventricle Physiology

Study Overview
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Brief Summary
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The purpose of this study is to determine if children with heart disease where there is only one pumping chamber(ventricle) have proteins (biomarkers) in the blood that can be used to monitor the function of their heart.

Detailed Description
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We will investigate whether levels of blood proteins in children with well-functioning hearts with one (single) ventricle are similar to levels of these blood proteins in children with two ventricles. For children with hearts with a single ventricle, we will examine blood proteins at various levels of heart function. To assess blood protein levels, we will collect small (6 mL) samples of blood. Heart function will be determined by existing clinical scoring systems. Enrolled patients will receive an echocardiogram, which is a dynamic ultrasound picture of the beating heart.

Official Title
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Identification of Biomarkers for Heart Failure in Children With Single Ventricle Physiology

Conditions
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Tricuspid Atresia, Hypoplastic Left Heart Syndrome, Unbalanced AV Canal

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with a structurally normal heart and a patent ductus arteriosus. Children with single ventricle physiology. Exclusion Criteria: Children must not have chromosomal abnormalities. Small deletions, such as that which produces DiGeorge syndrome, are permissible. Children with acute intercurrent non-cardiac inflammatory illness (such as post-operative wound infection) are ineligible, as such conditions may cause elevated blood levels of the proteins under study.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Group one consists of children 1 month - 6 years old who have structurally normal hearts, no heart failure, and a patent ductus arteriosus (PDA). | |
| 2<br>Group two consists of children 1 month - 6 years old who have single ventricle physiology. Children with and without heart failure may participate. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart failure, as assessed by clinical scoring systems. |  | Cross-sectional. We will obtain blood samples and assess for heart failure (function) concurrently when patients present to the Pediatric Heart Center | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiographic indices. |  | Cross-sectional | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single Ventricle, Congenital Heart Disease, Children, Fontan, Tricuspid Atresia, Hypoplastic Left Heart Syndrome, Heart Failure, Biomarkers, Single ventricle physiology such as:, unbalanced AV canal, Interested in patients both before and after Fontan Surgery