Biomarker Study for Heart Failure in Children With Single Ventricle Physiology

Completed

• Conditions: Unbalanced AV Canal; Tricuspid Atresia; Hypoplastic Left Heart Syndrome

• Registration Number: NCT00571233
• Lead Sponsor: University of California, San Francisco

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 Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-12-05
• Study First Submitted QC: 2007-12-07
• Study First Posted: 2007-12-11
• Primary Completion: 2011-12
• Study Completion: 2015-01
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-13
• Last Update Posted: 2015-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Echocardiographic indices.	Cross-sectional

Trial Locations

Locations (1)

Pediatric Heart Center, University of California, San Francisco; 🇺🇸 San Francisco, California, United States