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

This study has been completed.
Information provided by (Responsible Party):
University of California, San Francisco Identifier:
First received: December 5, 2007
Last updated: May 13, 2015
Last verified: May 2015
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.

Tricuspid Atresia
Hypoplastic Left Heart Syndrome
Unbalanced AV Canal

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

Resource links provided by NLM:

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 ]

Secondary Outcome Measures:
  • Echocardiographic indices. [ Time Frame: Cross-sectional ]

Biospecimen Retention:   Samples With DNA

Enrollment: 71
Study Start Date: February 2007
Study Completion Date: January 2015
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Group one consists of children 1 month - 6 years old who have structurally normal hearts, no heart failure, and a patent ductus arteriosus (PDA).
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.

Ages Eligible for Study:   1 Month to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting to the UCSF Pediatric Heart Center.

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.
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Please refer to this study by its identifier: NCT00571233

United States, California
Pediatric Heart Center, University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Principal Investigator: Harold Bernstein, MD, PhD UCSF Pediatric Cardiology
  More Information

Additional Information:
Responsible Party: University of California, San Francisco Identifier: NCT00571233     History of Changes
Other Study ID Numbers: 2529
Study First Received: December 5, 2007
Last Updated: May 13, 2015

Keywords provided by University of California, San Francisco:
Hypoplastic Left Heart Syndrome
Single Ventricle
Congenital Heart Disease
Tricuspid Atresia
Heart Failure
Single ventricle physiology such as:
unbalanced AV canal
Interested in patients both before and after Fontan Surgery

Additional relevant MeSH terms:
Heart Failure
Hypoplastic Left Heart Syndrome
Tricuspid Atresia
Heart Diseases
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Heart Valve Diseases processed this record on May 22, 2017