The Cardiovascular Comorbidity in Children With Chronic Kidney Disease Study (4C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01046448
Recruitment Status : Unknown
Verified January 2010 by Heidelberg University.
Recruitment status was:  Recruiting
First Posted : January 12, 2010
Last Update Posted : January 12, 2010
KfH Foundation for Preventive Medicine
German Federal Ministry of Education and Research
Information provided by:
Heidelberg University

Brief 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.

Condition or disease
Chronic Kidney Disease Pediatric Cardiovascular Disease

Detailed Description:

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.

Study Type : Observational
Estimated Enrollment : 650 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Cardiovascular Morbidity in Children With Chronic Renal Failure Study
Study Start Date : July 2009
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Children with chronic kidney disease stage IIIb to V (GFR 10 to 45 ml/min/1.73m²) at screening.

Primary Outcome Measures :
  1. 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 [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Genetic risk factors for early manifesting progressive vascular lesions and progressive kidney disease by the genome-wide SNP-screening and haplotype analysis. [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
serum, whole blood, urine, DNA, vessel biopsies,

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
650 children with CKD stage IIIb to V (GFR 10-45 ml/min/1.73m²). Children who reach end-stage renal disease will be continuously followed while on renal replacement therapy.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01046448

Contact: Franz S Schaefer, MD +49 6221 56 ext 2349
Contact: Elke Wühl, MD +49 6221 56 ext 39318

  Show 50 Study Locations
Sponsors and Collaborators
Heidelberg University
KfH Foundation for Preventive Medicine
German Federal Ministry of Education and Research
Principal Investigator: Franz Schaefer, MD Center for Pediatric and Adolescent Medicine, University of Heidelberg, Germany
Principal Investigator: Uwe Querfeld, MD Klinik für Pädiatrie m.S. Nephrologie, Charite, 13353 Berlin, Germany

Additional Information:
Responsible Party: Prof. Dr. med. Dr. h.c. Franz Schaefer, Center for Paediatrics and Adolescent Medicine, University of Heidelberg, Heidelberg, Germany Identifier: NCT01046448     History of Changes
Other Study ID Numbers: S-32/2009
First Posted: January 12, 2010    Key Record Dates
Last Update Posted: January 12, 2010
Last Verified: January 2010

Keywords provided by Heidelberg University:
chronic renal failure
chronic kidney disease
cardiovascular disease
cardiovascular morbidity
left ventricular hypertrophy
carotid intima media thickness
arterial stiffness
pulse wave velocity
augmentation index
left ventricular cardiac function
genetic risk factors
whole genome analysis
haplotype analysis

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency