Biomarker Study for Heart Failure in Children With Single Ventricle Physiology - Full Text View

Sponsored by:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00571233

Purpose

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.

Condition
Tricuspid Atresia Hypoplastic Left Heart Syndrome Unbalanced AV Canal

MedlinePlus related topics: Heart Diseases Heart Failure

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Cross-Sectional
Official Title:	Identification of Biomarkers for Heart Failure in Children With Single Ventricle Physiology

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Echocardiographic indices. [ Time Frame: Cross-sectional ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Serum

Estimated Enrollment:	40
Study Start Date:	February 2007
Estimated Study Completion Date:	February 2009

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

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

Ages Eligible for Study:	1 Month to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Patients presenting to the UCSF Pediatric Heart Center.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571233

Contacts

Contact: Harold Bernstein, MD, PhD	415-514-0236	harold.bernstein@ucsf.edu
Contact: Amee Shah, MD	415-443-5102	amee.shah@ucsf.edu

Locations

United States, California
Pediatric Heart Center, University of California, San Francisco	Recruiting
San Francisco, California, United States, 94143
Principal Investigator: Harold Bernstein, MD, PhD

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator:

Harold Bernstein, MD, PhD

UCSF Pediatrics Cardiology and CVRI

More Information

Responsible Party:	Pediatric Heart Center, University of California, San Francisco ( Harold Bernstein, MD, PhD )
Study ID Numbers:	2529
Study First Received:	December 5, 2007
Last Updated:	December 7, 2007
ClinicalTrials.gov Identifier:	NCT00571233
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

Single Ventricle
Congenital Heart Disease
Children
Fontan
Tricuspid Atresia
Hypoplastic Left Heart Syndrome
Heart Failure

Biomarkers
Single ventricle physiology such as:
tricuspid atresia
hypoplastic left heart syndrome
unbalanced AV canal
Interested in patients both before and after Fontan Surgery

Study placed in the following topic categories:

Heart Failure
Tricuspid Atresia
Heart Diseases
Cardiovascular Abnormalities
Hypoplastic Left Heart Syndrome
Single ventricular heart

Tricuspid atresia
Congenital Abnormalities
Hypoplastic left heart syndrome
Heart Defects, Congenital
Heart Valve Diseases

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009