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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Heidelberg University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
KfH Foundation for Preventive Medicine
German Federal Ministry of Education and Research
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT01046448
First received: August 7, 2009
Last updated: January 11, 2010
Last verified: January 2010
  Purpose

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
Chronic Kidney Disease
Pediatric
Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Cardiovascular Morbidity in Children With Chronic Renal Failure Study

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

serum, whole blood, urine, DNA, vessel biopsies,


Estimated Enrollment: 650
Study Start Date: July 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
4C
Children with chronic kidney disease stage IIIb to V (GFR 10 to 45 ml/min/1.73m²) at screening.

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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046448

Contacts
Contact: Franz S Schaefer, MD +49 6221 56 ext 2349 franz.schaefer@med.uni-heidelberg.de
Contact: Elke Wühl, MD +49 6221 56 ext 39318 elke.wuehl@med.uni-heidelberg.de

  Show 50 Study Locations
Sponsors and Collaborators
Heidelberg University
KfH Foundation for Preventive Medicine
German Federal Ministry of Education and Research
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Dr. med. Dr. h.c. Franz Schaefer, Center for Paediatrics and Adolescent Medicine, University of Heidelberg, Heidelberg, Germany
ClinicalTrials.gov Identifier: NCT01046448     History of Changes
Other Study ID Numbers: S-32/2009
Study First Received: August 7, 2009
Last Updated: January 11, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Heidelberg University:
Children
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
progression
genetic risk factors
vasculopathy
cardiopathy
whole genome analysis
haplotype analysis
SNP-screening

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

ClinicalTrials.gov processed this record on October 23, 2014