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

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Medical Conditions
  • Chronic Kidney Disease
  • Pediatric
  • Cardiovascular Disease
Primary Contact Details
Recruiting
Recruitment Status
NCT01046448
Primary Trial ID Number

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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.
Research Details
  • Adult patients with CKD are at markedly increased risk of dying from cardiovascular events. The risk is most dramatically increased in young patients with end-stage renal disease, who are almost as likely to die from cardiovascular causes as elderly individuals in the general population.

    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.
Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Study Type
Observational
Intervention
Sorry, this information is not available
Intervention Type
See Interventions above
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
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
6 Years - 17 Years
Who Can Participate
Patients
Number of Participants
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
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Site GB45
London
WC1N3JH
Trial Contact(s)
Primary Trial Contact
Franz S Schaefer, MD
2349 +49 6221 56
Other Trial Contacts
Elke Wühl, MD
39318 +49 6221 56
Countries Recruiting
Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Lithuania, Poland, Portugal, Serbia, Sweden, Switzerland, Turkey, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
The Cardiovascular Morbidity in Children With Chronic Renal Failure Study
EudraCT Number
Not available for this trial
Funder(s)
  • KfH Foundation for Preventive Medicine
  • German Federal Ministry of Education and Research
Other Study ID Numbers
S-32/2009
Sponsor(s)
Heidelberg University
Key Dates

Recruitment Start Date

Jul 2009

Recruitment End Date

Apr 2014

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

07 Aug 2009

Date updated in source

11 Jan 2010