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Completed

NCT Number: NCT00571233

Biomarker Study for Heart Failure in Children With Single Ventricle Physiology

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.

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Key information

Conditions

Tricuspid Atresia Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Failure Heart Valve Diseases Hypoplastic Left Heart Syndrome Unbalanced AV Canal Univentricular Heart

Age range

1 month–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pediatric Heart Center, University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Acronym: BHFSVP

Important dates

Study start
2007
Primary completion
2011
Study completion
2015
First posted
Dec 11, 2007
Registry last updated
May 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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