Clinical trial NCT00571233: Biomarker Study for Heart Failure in Children With Single Ventricle Physiology
Official title: Identification of Biomarkers for Heart Failure in Children With Single Ventricle Physiology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tricuspid Atresia
Hypoplastic Left Heart Syndrome
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
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2007-12-11
Enrollment: 71
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the UCSF Pediatric Heart Center.

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.

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.

Primary outcomes:
measure: Heart failure, as assessed by clinical scoring systems.
timeFrame: Cross-sectional. We will obtain blood samples and assess for heart failure (function) concurrently when patients present to the Pediatric Heart Center
Secondary outcomes:
measure: Echocardiographic indices.
timeFrame: Cross-sectional
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Pediatric Heart Center, University of California, San Francisco
state: California
Study officials:
affiliation: UCSF Pediatric Cardiology
name: Harold Bernstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shah A, Feraco AM, Harmon C, Tacy T, Fineman JR, Bernstein HS. Usefulness of various plasma biomarkers for diagnosis of heart failure in children with single ventricle physiology. Am J Cardiol. 2009 Nov 1;104(9):1280-4. doi: 10.1016/j.amjcard.2009.06.046.
citation: Lowenthal A, Shah A, Bernstein HS. Letter by Lowenthal et al regarding article, "BNP levels predict outcome in pediatric heart failure patients: post hoc analysis of the Pediatric Carvedilol Trial". Circ Heart Fail. 2010 Nov;3(6):e32; author reply e33. doi: 10.1161/CIRCHEARTFAILURE.110.958470. No abstract available.
citation: Lowenthal A, Camacho BV, Lowenthal S, Natal-Hernandez L, Liszewski W, Hills NK, Fineman JR, Bernstein HS. Usefulness of B-type natriuretic peptide and N-terminal pro-B-type natriuretic peptide as biomarkers for heart failure in young children with single ventricle congenital heart disease. Am J Cardiol. 2012 Mar 15;109(6):866-72. doi: 10.1016/j.amjcard.2011.10.049. Epub 2011 Dec 22.