Biomarker Study for Heart Failure in Children With Single Ventricle Physiology

Hypoplastic Left Heart Syndrome Clinical Trial

— BHFSVP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00571233
• Other study ID #: 2529
• Status: Completed
• Phase: N/A
• First received: December 5, 2007
• Last updated: May 13, 2015
• Start date: February 2007
• Est. completion date: January 2015

Study information

• Verified date: May 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: January 2015
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 6 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Heart Failure
• Hypoplastic Left Heart Syndrome
• Tricuspid Atresia
• Unbalanced AV Canal

Locations

Country	Name	City	State
United States	Pediatric Heart Center, University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 — View 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. do — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Echocardiographic indices.		Cross-sectional	No

External Links

•   Letter by Lowenthal et al regarding article, "BNP levels predict outcome in pediatric heart failure patients: post hoc analysis of the Pediatric Carvedilol Trial"
•   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
•   Usefulness of Various Plasma Biomarkers for Diagnosis of Heart Failure in Children with Single Ventricle Physiology