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Clinical Trials/NCT00571233
NCT00571233
Completed
Not Applicable

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

University of California, San Francisco1 site in 1 country71 target enrollmentFebruary 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tricuspid Atresia
Sponsor
University of California, San Francisco
Enrollment
71
Locations
1
Primary Endpoint
Heart failure, as assessed by clinical scoring systems.
Status
Completed
Last Updated
10 years ago

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.

Registry
clinicaltrials.gov
Start Date
February 2007
End Date
January 2015
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Study Sites (1)

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