The Cardiovascular Comorbidity in Children With Chronic Kidney Disease Study

Cardiovascular Disease Clinical Trial

— 4C  

Official title:

The Cardiovascular Morbidity in Children With Chronic Renal Failure Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01046448
• Other study ID #: S-32/2009
• Status: Recruiting
• Phase: N/A
• First received: August 7, 2009
• Last updated: January 11, 2010
• Start date: July 2009
• Est. completion date: April 2014

Study information

• Verified date: January 2010
• Source: Heidelberg University
• Contact: Franz S Schaefer, MD
• Phone: +49 6221 56
• Email: franz.schaefer[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Chronic Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Pediatric
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna
Belgium	UZ Gent	Gent
Czech Republic	University Hospital Motol	Prague
France	Service de Pédiatrie & Inserm U820	Lyon
France	Hôpital de Hautepierre	Strasbourg
Germany	Charité Children's Hospital	Berlin
Germany	University Children's Hospital	Cologne
Germany	University Children's Hospital	Erlangen
Germany	University Children's Hospital	Essen
Germany	Center for Pediatrics and Adolescent Medicine	Freiburg
Germany	UKE University Children's Hospital	Hamburg
Germany	Hannover Medical School	Hannover
Germany	Center for Pediatrics and Adolescent Medicine	Heidelberg
Germany	City Hospital St. Georg	Leipzig
Germany	KfH Kidney Center for Children	Marburg
Germany	University Children's Hospital	Münster
Germany	Children's Hospital	Rostock
Hungary	Semmelweis University	Budapest
Italy	S. Orsola-Malphighi Hospital	Bologna
Italy	Istituto Giannina Gaslini	Genova
Italy	Fondazione OSP Maggiore Policlinico	Milano
Italy	University of Padova	Padova
Italy	Bambino Gesu	Rome
Italy	Regina Margherita Children's Hospital	Torino
Lithuania	Vilnius University Children's Hospital	Vilnius
Poland	Medical University Gdansk	Gdansk
Poland	University Children's Hospital	Krakow
Poland	Clinic of Pediatrics	Szczecin
Poland	Children's Memorial Health Institute	Warsaw
Portugal	Hospital Sao Joao	Porto
Serbia	University Children's Hospital	Belgrade
Sweden	Karolinska University Hospital	Stockholm
Switzerland	Inselspital	Bern
Switzerland	University Children's Hospital	Zurich
Turkey	Cukurova Universitesi	Adana
Turkey	Ankara University of Medicine	Ankara
Turkey	Baskent University, Faculty of Medicine	Ankara
Turkey	Diskapi Childrens Hospital	Ankara
Turkey	Gazi University Hospital	Ankara
Turkey	Hacettepe Medical Faculty	Ankara
Turkey	Sami Ulus Childrens Hospital	Ankara
Turkey	Bakirkoy Children's Hospital	Istanbul
Turkey	Cerrahpasa Tip Fakultesi	Istanbul
Turkey	Goztepe Educational and Research Hospital	Istanbul
Turkey	Haseki Educational and Research Hospital	Istanbul
Turkey	Istanbul Medical Faculty	Istanbul
Turkey	Marmara University Medical Faculty	Istanbul
Turkey	Sisli Educational and Research Hospital	Istanbul
Turkey	Ege University	Izmir
United Kingdom	Great Ormond Street Hospital	London

Sponsors (3)

Lead Sponsor	Collaborator
Heidelberg University	German Federal Ministry of Education and Research, KfH Foundation for Preventive Medicine

Countries where clinical trial is conducted

Austria,  Belgium,  Czech Republic,  France,  Germany,  Hungary,  Italy,  Lithuania,  Poland,  Portugal,  Serbia,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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

External Links

•   Click here for more information about this study: 4C-Study