Biomarker Study for Heart Failure in Children With Single Ventricle Physiology

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00571233

Acronym

BHFSVP

Enrollment

Registered

2007-12-11

Start date

2007-02-28

Completion date

2015-01-31

Last updated

2015-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoplastic Left Heart Syndrome, Tricuspid Atresia, Unbalanced AV Canal

Keywords

Single Ventricle, Congenital Heart Disease, Children, Fontan, Tricuspid Atresia, Hypoplastic Left Heart Syndrome, Heart Failure, Biomarkers, Single ventricle physiology such as:, unbalanced AV canal, Interested in patients both before and after Fontan Surgery

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

1 Months to 6 Years

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Echocardiographic indices.	Cross-sectional

Countries

United States

Outcome results