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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00571233
First received: December 5, 2007
Last updated: March 1, 2012
Last verified: March 2012
History of Changes
  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

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:

U.S. FDA Resources

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

Serum


Estimated Enrollment: 75
Study Start Date: February 2007
Estimated Study Completion Date: January 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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:   No
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

Locations
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
Investigators
Principal Investigator: Harold Bernstein, MD, PhD UCSF Pediatric Cardiology
  More Information

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

Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00571233     History of Changes
Other Study ID Numbers: 2529
Study First Received: December 5, 2007
Last Updated: March 1, 2012
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

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

ClinicalTrials.gov processed this record on May 21, 2013