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

Tracking Information

First Received Date ^ICMJE

December 5, 2007

Last Updated Date

May 13, 2015

Start Date ^ICMJE

February 2007

Primary Completion Date

December 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00571233 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Echocardiographic indices. [ Time Frame: Cross-sectional ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Biomarker Study for Heart Failure in Children With Single Ventricle Physiology

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Serum

Sampling Method

Non-Probability Sample

Study Population

Patients presenting to the UCSF Pediatric Heart Center.

Condition ^ICMJE

Tricuspid Atresia
Hypoplastic Left Heart Syndrome
Unbalanced AV Canal

Intervention ^ICMJE

Not Provided

Study 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.

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2015

Primary Completion Date

December 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

1 Month to 6 Years (Child)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00571233

Other Study ID Numbers ^ICMJE

2529

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

University of California, San Francisco

Study Sponsor ^ICMJE

University of California, San Francisco

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Harold Bernstein, MD, PhD

UCSF Pediatric Cardiology

PRS Account

University of California, San Francisco

Verification Date

May 2015

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

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