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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00571233
First Posted: December 11, 2007
Last Update Posted: May 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, San Francisco
  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:


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 ]

Secondary Outcome Measures:
  • Echocardiographic indices. [ Time Frame: Cross-sectional ]

Biospecimen Retention:   Samples With DNA
Serum

Enrollment: 71
Study Start Date: February 2007
Study Completion Date: January 2015
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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 6 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00571233     History of Changes
Other Study ID Numbers: 2529
First Submitted: December 5, 2007
First Posted: December 11, 2007
Last Update Posted: May 14, 2015
Last Verified: May 2015

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:
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


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