Biomarker Study for Heart Failure in Children With Single Ventricle Physiology (BHFSVP)
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.
Hypoplastic Left Heart Syndrome
Unbalanced AV Canal
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Identification of Biomarkers for Heart Failure in Children With Single Ventricle Physiology|
- 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 ] [ Designated as safety issue: No ]
- Echocardiographic indices. [ Time Frame: Cross-sectional ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||February 2007|
|Estimated Study Completion Date:||January 2015|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Group one consists of children 1 month - 6 years old who have structurally normal hearts, no heart failure, and a patent ductus arteriosus (PDA).
Group two consists of children 1 month - 6 years old who have single ventricle physiology. Children with and without heart failure may participate.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00571233
|United States, California|
|Pediatric Heart Center, University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Harold Bernstein, MD, PhD||UCSF Pediatric Cardiology|