Biomarker Study for Heart Failure in Children With Single Ventricle Physiology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-02-28

Study Completion Date

2015-01-31

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.

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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.

Conditions

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Tricuspid Atresia Hypoplastic Left Heart Syndrome Unbalanced AV Canal

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

Group one consists of children 1 month - 6 years old who have structurally normal hearts, no heart failure, and a patent ductus arteriosus (PDA).

No interventions assigned to this group

2

Group two consists of children 1 month - 6 years old who have single ventricle physiology. Children with and without heart failure may participate.

No interventions assigned to this group

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.

Minimum Eligible Age

1 Month

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No