The Cardiovascular Comorbidity in Children With Chronic Kidney Disease Study | Recruiting
The Cardiovascular Comorbidity in Children With Chronic Kidney Disease Study
4C
Trial Source

Health Conditions
  • Chronic Kidney Disease
  • Pediatric
  • Cardiovascular Disease
Recruiting
Recruitment Status
NCT01046448
Primary Trial ID Number
Summary
Children and adolescents with chronic kidney disease (CKD) are at high risk for cardiovascular (CV) morbidity and mortality. Recent studies suggest that pediatric patients with even moderately impaired kidney function may be afflicted with significant early cardiac and vascular abnormalities. 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.
Primary Outcome Measures
  • Functional and morphological evidence of cardiovascular disease progression (arterial stiffness, myocardial dysfunction, cIMT, LVMI) and association with clinical, anamnestic, anthropometric, biochemical, drug-related and genetic risk factors; 3 years
Secondary Outcome Measures
  • Genetic risk factors for early manifesting progressive vascular lesions and progressive kidney disease by the genome-wide SNP-screening and haplotype analysis.; 3 years
Research Question
  • Children and adolescents with chronic kidney disease (CKD) are at high risk for cardiovascular (CV) morbidity and mortality. Recent studies suggest that pediatric patients with even moderately impaired kidney function may be afflicted with significant early cardiac and vascular abnormalities. 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.
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
Austria; Belgium; Czech Republic; France; Germany; Hungary; Italy; Lithuania; Poland; Portugal; Serbia; Sweden; Switzerland; Turkey; United Kingdom
Participant Sex
Both
Participant Age Range
6 Years to 17 Years
Participant Type
Sorry, this information is not available
Trial Sample Size
650
Participant Inclusion Criteria
  • Inclusion Criteria:
  • - Age 6 to 17 years
  • - GFR 10 to 45 ml/min/1.73m² (CKD stage IIIb to V);
  • Exclusion Criteria:
  • - Active systemic vasculitis
  • - Diabetes mellitus
  • - Renal vascular anomalies
  • - Anomalies of the limbs preventing standardized diagnostic procedures
Participant Exclusion Criteria
  • Inclusion Criteria:
  • - Age 6 to 17 years
  • - GFR 10 to 45 ml/min/1.73m² (CKD stage IIIb to V);
  • Exclusion Criteria:
  • - Active systemic vasculitis
  • - Diabetes mellitus
  • - Renal vascular anomalies
  • - Anomalies of the limbs preventing standardized diagnostic procedures
Interventions
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Design Details
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Study Design
Observational Model: Cohort, Time Perspective: Prospective
Results Reporting
Sorry, this information is not available
Acronym
4C
Scientific Title
The Cardiovascular Morbidity in Children With Chronic Renal Failure Study
Secondary Trial Identifying Number
Sorry, this information is not available
Website
http://www.4C-study.org
Study Funded By
Heidelberg University
Funder Type
Sorry, this information is not available
Study Sponsored By
Heidelberg University
Study Also Sponsored By
KfH Foundation for Preventive Medicine; German Federal Ministry of Education and Research
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

07 Aug 2009

Last Updated

11 Jan 2010

Date Record Refreshed on UKCTG

31 Jul 2015