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
  Scientific Title	The Cardiovascular Morbidity in Children With Chronic Renal Failure Study
  Acronym	4C
  Primary Trial Identifying Number	NCT01046448
  Secondary Identifying Number	Sorry, not currently available
  Source of Record	Information obtained from ClinicalTrials.gov on April 14, 2013
  Source of Record URL	http://clinicaltrials.gov/show/NCT01046448
  Date of Registration	2009-08-07
  Date Last Updated	2010-01-11
  Date Record Refreshed on UKCTG	2013-04-16

• Trial

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  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. (from ClinicalTrials.gov)
  Ethics Approval	Sorry, not currently available
  Study Design	Observational Model: Cohort, Time Perspective: Prospective
  Design Type	Sorry, not currently available
  Design Details	Sorry, not currently available
  Health Condition(s) or Problem	Chronic Kidney Disease; Pediatric; Cardiovascular Disease
  Participants 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
  Participants 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
  Participant Sex	Sorry, not currently available
  Participant Age Range	Sorry, not currently available
  Participant Type	Sorry, not currently available
  Target Sample Size	650
  Date of First Enrolment	Sorry, not currently available
  Date of Recruitment End	Sorry, not currently available
  Date of End of Follow-up	Sorry, not currently available
  Trial End Date	Sorry, not currently available
  Recruitment Status	Recruiting
  Overall Trial Status	Sorry, not currently available
  Countries of Recruitment	Austria; Belgium; Czech Republic; France; Germany; Hungary; Italy; Lithuania; Poland; Portugal; Serbia; Sweden; Switzerland; Turkey; United Kingdom
  Nation	England
  Location	London
  Interventions	Sorry, not currently available
  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
  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; No
  Website	http://www.4C-study.org

• Results

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  Results Reporting	Sorry, not currently available
  Publications	Sorry, not currently available

• 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

• Sponsor

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  Study sponsored by	University of Heidelberg
  Study also sponsored by	KfH Foundation for Preventive Medicine; German Federal Ministry of Education and Research
  Primary Sponsor Type	Sorry, not currently available
  Secondary Sponsor Type	Sorry, not currently available

• Funder

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  Study funded by	University of Heidelberg
  Funder Type	Sorry, not currently available