Identification of Biomarkers for Heart Failure in Children With Single Ventricle Physiology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- Heart failure, as assessed by clinical scoring systems.
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 1 Month to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Heart failure, as assessed by clinical scoring systems.
Time Frame: Cross-sectional. We will obtain blood samples and assess for heart failure (function) concurrently when patients present to the Pediatric Heart Center
Secondary Outcomes
- Echocardiographic indices.(Cross-sectional)