The Cardiovascular Comorbidity in Children With Chronic Kidney Disease Study

Recruiting

• Source

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  Public Title	The Cardiovascular Comorbidity in Children With Chronic Kidney Disease Study
  Acronym	4C
  Source of Record URL	http://clinicaltrials.gov/show/NCT01046448

• Trial

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  Health Condition(s) or Problem	Chronic Kidney Disease; Pediatric; Cardiovascular Disease
  Lay 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. (from ClinicalTrials.gov)
  Who can enter the trial	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
  Who cannot enter the trial	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
  What will happen	Sorry, not currently available
  Primary aim	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
  Secondary Aim	Genetic risk factors for early manifesting progressive vascular lesions and progressive kidney disease by the genome-wide SNP-screening and haplotype analysis.; 3 years; No
  Participant Information Sheet	Sorry, not currently available
  Website	http://www.4C-study.org
  Recruitment Status	Recruiting
  Nation	England
  Location	London

• Contact

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  Contact for Public Queries	Franz S Schaefer, MD +49 6221 56 franz.schaefer@med.uni-heidelberg.de Franz Schaefer, MD; Uwe Querfeld, MD Principal Investigator; Principal Investigator Center for Pediatric and Adolescent Medicine, University of Heidelberg, Germany; Klinik für Pädiatrie m.S. Nephrologie, Charite, 13353 Berlin, Germany
  Contact for Scientific Queries	René Zeller, MD; Sub-Investigator; Daniela Kracht, MD; Sub-Investigator; Anke Doyon, MD; Sub-Investigator; Mieczyslaw Litwin, MD; Sub-Investigator; Aysun Bayazit, MD; Sub-Investigator; Ali Duzova, MD; Sub-Investigator; Mahmut Civilibal, MD; Sub-Investigator; Betül Sözeri, MD; Sub-Investigator