Biomarker Study for Heart Failure in Children With Single Ventricle Physiology (BHFSVP)

University of California San Francisco (UCSF)

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT00571233

2529

Details and patient eligibility

About

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.

Full 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.

Enrollment: 71 patients

Sex: All

Ages: 1 month to 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

71 participants in 2 patient groups

1

Description:

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

2

Description:

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