Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-02-27 @ 11:58 AM
Study NCT ID:
NCT00571233
Status:
COMPLETED
Last Update Posted:
2015-05-14
First Post:
2007-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarker Study for Heart Failure in Children With Single Ventricle Physiology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018785', 'term': 'Tricuspid Atresia'}, {'id': 'D018636', 'term': 'Hypoplastic Left Heart Syndrome'}, {'id': 'D000080039', 'term': 'Univentricular Heart'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-13', 'studyFirstSubmitDate': '2007-12-05', 'studyFirstSubmitQcDate': '2007-12-07', 'lastUpdatePostDateStruct': {'date': '2015-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart failure, as assessed by clinical scoring systems.', 'timeFrame': 'Cross-sectional. We will obtain blood samples and assess for heart failure (function) concurrently when patients present to the Pediatric Heart Center'}], 'secondaryOutcomes': [{'measure': 'Echocardiographic indices.', 'timeFrame': 'Cross-sectional'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['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'], 'conditions': ['Tricuspid Atresia', 'Hypoplastic Left Heart Syndrome', 'Unbalanced AV Canal']}, 'referencesModule': {'references': [{'pmid': '19840577', 'type': 'RESULT', 'citation': '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': '21081737', 'type': 'RESULT', 'citation': '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': '22196786', 'type': 'RESULT', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2791782/?tool=pubmed', 'label': 'Usefulness of Various Plasma Biomarkers for Diagnosis of Heart Failure in Children with Single Ventricle Physiology'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed/21081737', 'label': 'Letter by Lowenthal et al regarding article, "BNP levels predict outcome in pediatric heart failure patients: post hoc analysis of the Pediatric Carvedilol Trial"'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed/22196786', 'label': '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'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting to the UCSF Pediatric Heart Center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with a structurally normal heart and a patent ductus arteriosus.\n* Children with single ventricle physiology.\n\nExclusion Criteria:\n\n* Children must not have chromosomal abnormalities. Small deletions, such as that which produces DiGeorge syndrome, are permissible.\n* 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.'}, 'identificationModule': {'nctId': 'NCT00571233', 'acronym': 'BHFSVP', 'briefTitle': 'Biomarker Study for Heart Failure in Children With Single Ventricle Physiology', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Identification of Biomarkers for Heart Failure in Children With Single Ventricle Physiology', 'orgStudyIdInfo': {'id': '2529'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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).'}, {'label': '2', 'description': 'Group two consists of children 1 month - 6 years old who have single ventricle physiology. Children with and without heart failure may participate.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Pediatric Heart Center, University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Harold Bernstein, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSF Pediatric Cardiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}