The Cardiovascular Comorbidity in Children With Chronic Kidney Disease Study
NCT ID: NCT01046448
Last Updated: 2010-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
650 participants
OBSERVATIONAL
2009-07-31
2014-04-30
Brief Summary
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The pathogenesis and the natural course of CV comorbidity in pediatric CKD patients is still elusive. In this multicenter, prospective, observational study the prevalence, degree and progression of CV comorbidity in children will be characterized and related to CKD progression. The morphology and function of the heart and vessels will be monitored by sensitive, non-invasive methods and will be compared with aged matched healthy controls. Multiple potential clinical, anthropometric, biochemical, and pharmacological risk factors will be monitored prospectively and will be related to CV status. Genotyping might identify predisposing genetic factors for progression of CV comorbidity and underlying nephropathies.
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Detailed Description
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Early morphological and functional vascular abnormalities can be detected even in adolescents with CKD, but information about the prevalence, severity and natural course of vascular lesions in different stages of renal failure is lacking and the factors predisposing to an early onset and rapid progression of cardiovascular morbidity are still elusive.
The pediatric population appears uniquely suited to study the effects of CKD on the cardiovascular system due to the virtual absence of vascular morbidity related to ageing, diabetes and smoking.
In order to improve our understanding of the causes and consequences of cardiovascular comorbidity in children with progressive CKD, a consortium of pediatric nephrologists in Europe has joined to perform a long-term prospective observational study following the cardiovascular health of children as they advance through successive stages of CKD.
The 4C Study will follow up at least 625 patients aged 6 to 17 years with a glomerular filtration rate of 10 to 45 ml/min/1.73 m² in more than 40 pediatric nephrology units in 14 European countries.
The morphology and function of the heart and the large arteries is regularly assessed by sensitive, non-invasive methods and the findings compared to a large group of healthy children.
Multiple potential clinical, anthropometric, biochemical, and pharmacological risk factors are monitored prospectively and will be related to the cardiovascular status of the patients.
A whole genome association study will be performed to identify genetic variants associated with the progression of cardio-vascular alterations and renal failure.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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4C
Children with chronic kidney disease stage IIIb to V (GFR 10 to 45 ml/min/1.73m²) at screening.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* GFR 10 to 45 ml/min/1.73m² (CKD stage IIIb to V);
Exclusion Criteria
* Diabetes mellitus
* Renal vascular anomalies
* Anomalies of the limbs preventing standardized diagnostic procedures
6 Years
17 Years
ALL
No
Sponsors
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KfH Foundation for Preventive Medicine
UNKNOWN
German Federal Ministry of Education and Research
OTHER_GOV
Heidelberg University
OTHER
Responsible Party
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Center for Paediatrics and Adolescent Medicine, University of Heidelberg, Heidelberg, Germany
Principal Investigators
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Franz Schaefer, MD
Role: PRINCIPAL_INVESTIGATOR
Center for Pediatric and Adolescent Medicine, University of Heidelberg, Germany
Uwe Querfeld, MD
Role: PRINCIPAL_INVESTIGATOR
Klinik für Pädiatrie m.S. Nephrologie, Charite, 13353 Berlin, Germany
Locations
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Medical University of Vienna
Vienna, , Austria
UZ Gent
Ghent, , Belgium
University Hospital Motol
Prague, , Czechia
Service de Pédiatrie & Inserm U820
Lyon, , France
Hôpital de Hautepierre
Strasbourg, , France
Charité Children's Hospital
Berlin, , Germany
University Children's Hospital
Cologne, , Germany
University Children's Hospital
Erlangen, , Germany
University Children's Hospital
Essen, , Germany
Center for Pediatrics and Adolescent Medicine
Freiburg im Breisgau, , Germany
UKE University Children's Hospital
Hamburg, , Germany
Hannover Medical School
Hanover, , Germany
Center for Pediatrics and Adolescent Medicine
Heidelberg, , Germany
City Hospital St. Georg
Leipzig, , Germany
KfH Kidney Center for Children
Marburg, , Germany
University Children's Hospital
Münster, , Germany
Children's Hospital
Rostock, , Germany
Semmelweis University
Budapest, , Hungary
S. Orsola-Malphighi Hospital
Bologna, , Italy
Istituto Giannina Gaslini
Genova, , Italy
Fondazione OSP Maggiore Policlinico
Milan, , Italy
University of Padova
Padua, , Italy
Bambino Gesu
Rome, , Italy
Regina Margherita Children's Hospital
Torino, , Italy
Vilnius University Children's Hospital
Vilnius, , Lithuania
Medical University Gdansk
Gdansk, , Poland
University Children's Hospital
Krakow, , Poland
Clinic of Pediatrics
Szczecin, , Poland
Children's Memorial Health Institute
Warsaw, , Poland
Hospital Sao Joao
Porto, , Portugal
University Children's Hospital
Belgrade, , Serbia
Karolinska University Hospital
Stockholm, , Sweden
Inselspital
Bern, , Switzerland
University Children's Hospital
Zurich, , Switzerland
Cukurova Universitesi
Adana, , Turkey (Türkiye)
Ankara University of Medicine
Ankara, , Turkey (Türkiye)
Hacettepe Medical Faculty
Ankara, , Turkey (Türkiye)
Gazi University Hospital
Ankara, , Turkey (Türkiye)
Baskent University, Faculty of Medicine
Ankara, , Turkey (Türkiye)
Diskapi Childrens Hospital
Ankara, , Turkey (Türkiye)
Sami Ulus Childrens Hospital
Ankara, , Turkey (Türkiye)
Cerrahpasa Tip Fakultesi
Istanbul, , Turkey (Türkiye)
Istanbul Medical Faculty
Istanbul, , Turkey (Türkiye)
Bakirkoy Children's Hospital
Istanbul, , Turkey (Türkiye)
Goztepe Educational and Research Hospital
Istanbul, , Turkey (Türkiye)
Haseki Educational and Research Hospital
Istanbul, , Turkey (Türkiye)
Marmara University Medical Faculty
Istanbul, , Turkey (Türkiye)
Sisli Educational and Research Hospital
Istanbul, , Turkey (Türkiye)
Ege University
Izmir, , Turkey (Türkiye)
Great Ormond Street Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Ali Duzova, MD
Role: primary
Related Links
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Click here for more information about this study: 4C-Study
Other Identifiers
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S-32/2009
Identifier Type: -
Identifier Source: org_study_id
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