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CompletedNCT00571233BHFSVPUpdated May 14, 2015

Biomarker Study for Heart Failure in Children With Single Ventricle Physiology

An observational study in Tricuspid Atresia, Hypoplastic Left Heart Syndrome and Unbalanced AV Canal, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 1 Month to 6 Years. Per ClinicalTrials.gov, last updated 2015-05-14.

Sponsored by University of California, San Francisco · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
71
Ages
1 Month to 6 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • 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
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In context

Hypoplastic Left Heart Syndrome

65 studies on the registry are indexed under Hypoplastic Left Heart Syndrome; 12 are open to participants now.

This study's enrollment of 71 is close to the median of 71 across 23 observational studies indexed under Hypoplastic Left Heart Syndrome.

Browse Hypoplastic Left Heart Syndrome studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,164 studies on the registry; 368 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 199 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Month to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients presenting to the UCSF Pediatric Heart Center.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children with a structurally normal heart and a patent ductus arteriosus.
  • Children with single ventricle physiology.

Exclusion criteria

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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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
71 participants (actual)
Biospecimen retention
Samples with dna

Groups and 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.

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What researchers measure

Primary outcomes

  1. 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 outcomes

  1. Echocardiographic indices.

    Time frame: Cross-sectional

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Study locations

1 site
  • Pediatric Heart Center, University of California, San Francisco
    San Francisco, California 94143, United States
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References and documents

Publications

  • 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. PubMed 19840577 ↗
  • 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. PubMed 21081737 ↗
  • 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. PubMed 22196786 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00571233
Responsible party
Sponsor
First posted
Dec 11, 2007
Start date
Feb 2007
Primary completion
Dec 2011
Completion
Jan 2015
Last update
May 14, 2015

Study contacts

Harold Bernstein, MD, PhD
principal investigator · UCSF Pediatric Cardiology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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