NCT00571233

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2007

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 11, 2007

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

May 14, 2015

Status Verified

May 1, 2015

Enrollment Period

4.8 years

First QC Date

December 5, 2007

Last Update Submit

May 13, 2015

Conditions

Tricuspid AtresiaHypoplastic Left Heart SyndromeUnbalanced AV Canal

Keywords

Single VentricleCongenital Heart DiseaseChildrenFontanTricuspid AtresiaHypoplastic Left Heart SyndromeHeart FailureBiomarkersSingle ventricle physiology such as:unbalanced AV canalInterested in patients both before and after Fontan Surgery

Outcome Measures

Primary Outcomes (1)

  • Heart failure, as assessed by clinical scoring systems.

    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.

    Cross-sectional

Study Arms (2)

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.

Eligibility Criteria

Age1 Month - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to the UCSF Pediatric Heart Center.

You may qualify if:

  • Children with a structurally normal heart and a patent ductus arteriosus.
  • Children with single ventricle physiology.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Heart Center, University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (3)

  • Shah A, Feraco AM, Harmon C, Tacy T, Fineman JR, Bernstein HS. Usefulness of various plasma biomarkers for diagnosis of heart failure in children with single ventricle physiology. Am J Cardiol. 2009 Nov 1;104(9):1280-4. doi: 10.1016/j.amjcard.2009.06.046.

    PMID: 19840577RESULT

  • Lowenthal A, Shah A, Bernstein HS. Letter by Lowenthal et al regarding article, "BNP levels predict outcome in pediatric heart failure patients: post hoc analysis of the Pediatric Carvedilol Trial". Circ Heart Fail. 2010 Nov;3(6):e32; author reply e33. doi: 10.1161/CIRCHEARTFAILURE.110.958470. No abstract available.

    PMID: 21081737RESULT

  • Lowenthal A, Camacho BV, Lowenthal S, Natal-Hernandez L, Liszewski W, Hills NK, Fineman JR, Bernstein HS. Usefulness of B-type natriuretic peptide and N-terminal pro-B-type natriuretic peptide as biomarkers for heart failure in young children with single ventricle congenital heart disease. Am J Cardiol. 2012 Mar 15;109(6):866-72. doi: 10.1016/j.amjcard.2011.10.049. Epub 2011 Dec 22.

    PMID: 22196786RESULT

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Serum

MeSH Terms

Conditions

Tricuspid AtresiaHypoplastic Left Heart SyndromeUniventricular HeartHeart Defects, CongenitalHeart Failure

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesHeart Valve DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Harold Bernstein, MD, PhD

    UCSF Pediatric Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2007

First Posted

December 11, 2007

Study Start

February 1, 2007

Primary Completion

December 1, 2011

Study Completion

January 1, 2015

Last Updated

May 14, 2015

Record last verified: 2015-05

Locations

US(1)