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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00571233
First received: December 5, 2007
Last updated: May 13, 2015
Last verified: May 2015
History of Changes

December 5, 2007
May 13, 2015
February 2007
December 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00571233 on ClinicalTrials.gov Archive Site
Echocardiographic indices. [ Time Frame: Cross-sectional ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Biomarker Study for Heart Failure in Children With Single Ventricle Physiology
Identification of Biomarkers 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.
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.
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:
Serum
Non-Probability Sample
Patients presenting to the UCSF Pediatric Heart Center.
  • Tricuspid Atresia
  • Hypoplastic Left Heart Syndrome
  • Unbalanced AV Canal
Not Provided
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
January 2015
December 2011   (final data collection date for primary outcome measure)

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.
Both
1 Month to 6 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00571233
2529
No
Not Provided
Not Provided
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Harold Bernstein, MD, PhD UCSF Pediatric Cardiology
University of California, San Francisco
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP