Biomarker Study for Heart Failure in Children With Single Ventricle Physiology

Brief Title

Biomarker Study for Heart Failure in Children With Single Ventricle Physiology

Official Title

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

Brief 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.
    

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.
    


Study Type

Observational


Primary Outcome

Heart failure, as assessed by clinical scoring systems.

Secondary Outcome

 Echocardiographic indices.

Condition

Tricuspid Atresia


Study Arms / Comparison Groups

 1
Description:  Group one consists of children 1 month - 6 years old who have structurally normal hearts, no heart failure, and a patent ductus arteriosus (PDA).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

71

Start Date

February 2007

Completion Date

January 2015

Primary Completion Date

December 2011

Eligibility 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.
      

Gender

All

Ages

1 Month - 6 Years

Accepts Healthy Volunteers

No

Contacts

Harold Bernstein, MD, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00571233

Organization ID

2529


Responsible Party

Sponsor

Study Sponsor

University of California, San Francisco


Study Sponsor

Harold Bernstein, MD, PhD, Principal Investigator, UCSF Pediatric Cardiology


Verification Date

May 2015