The Cardiovascular Comorbidity in Children With Chronic Kidney Disease Study (4C)
January 11, 2010 updated by: Heidelberg University
The Cardiovascular Morbidity in Children With Chronic Renal Failure Study
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.
Study Overview
Status
Unknown
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
Enrollment (Anticipated)
650
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Vienna, Austria, 1010
- Not yet recruiting
- Medical University of Vienna
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Contact:
- Klaus Arbeiter, MD
- Phone Number: +43 1 40400 3257
- Email: klaus.arbeiter@meduniwien.ac.at
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Gent, Belgium, 9000
- Not yet recruiting
- UZ Gent
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Contact:
- Johan Vande Walle, MD
- Phone Number: +32 9 332 2483
- Email: johan.vandewalle@ugent.be
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Prague, Czech Republic, 15006
- Not yet recruiting
- University Hospital Motol
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Contact:
- Jiri Dusek, MD
- Phone Number: +420 224 432 044
- Email: j.dusek@lfmotol.cuni.cz
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Lyon, France, 69677
- Not yet recruiting
- Service de Pédiatrie & Inserm U820
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Contact:
- Pierre Cochat, MD
- Phone Number: +33 4 72119338
- Email: pierre.cochat@chu-lyon.fr
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Strasbourg, France, 67098
- Not yet recruiting
- Hôpital de Hautepierre
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Contact:
- Michel Fischbach, MD
- Phone Number: +33 388127743
- Email: michel.fischbach@chru-strasbourg.fr
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Berlin, Germany, 13353
- Not yet recruiting
- Charité Children's Hospital
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Contact:
- René Zeller, MD
- Phone Number: +30 450 516 031
- Email: rene.zeller@charite.de
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Contact:
- Uwe Querfeld, MD
- Phone Number: +30 450 516 031
- Email: uwe.querfeld@charite.de
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Sub-Investigator:
- René Zeller, MD
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Cologne, Germany, 50937
- Not yet recruiting
- University Children's Hospital
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Contact:
- Bernd Hoppe, MD
- Email: bernd.hoppe@uk-koeln.de
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Erlangen, Germany, 91054
- Not yet recruiting
- University Children's Hospital
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Contact:
- Eva-Maria Rüth, MD
- Phone Number: +49 91318536097
- Email: eva-maria.rueth@uk-erlangen.de
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Essen, Germany, 45122
- Not yet recruiting
- University Children's Hospital
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Contact:
- Rainer Büscher, MD
- Phone Number: +49 201 723 3780
- Email: rainer.buescher@uk-essen.de
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Freiburg, Germany, 79106
- Not yet recruiting
- Center for Pediatrics and Adolescent Medicine
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Contact:
- Martin Pohl, MD
- Phone Number: +761 270 4531
- Email: martin.pohl@uniklinik-freiburg.de
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Hamburg, Germany, 20246
- Not yet recruiting
- UKE University Children's Hospital
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Contact:
- Dirk E. Mueller-Wiefel, MD
- Phone Number: +49 40 74105 2702
- Email: muellerw@uke.uni-hamburg.de
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Hannover, Germany, 30625
- Recruiting
- Hannover Medical School
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Contact:
- Daniela Kracht, MD
- Phone Number: +49 511 532 3213
- Email: kracht.daniela@mh-hannover.de
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Contact:
- Anette Melk, MD
- Phone Number: +49 511 532 5597
- Email: melk.anette@mh-hannover.de
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Sub-Investigator:
- Daniela Kracht, MD
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Heidelberg, Germany, 69120
- Recruiting
- Center for Pediatrics and Adolescent Medicine
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Contact:
- Elke Wühl, MD
- Phone Number: 39318 +49 6221 56
- Email: elke.wuehl@med.uni-heidelberg.de
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Contact:
- Anke Doyon, MD
- Phone Number: 37296 +49 6221 56
- Email: anke.doyon@med.uni-heidelberg.de
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Sub-Investigator:
- Anke Doyon, MD
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Leipzig, Germany, 04129
- Not yet recruiting
- City Hospital St. Georg
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Contact:
- Simone Wygoda, MD
- Phone Number: +49 3419093640
- Email: simone.wygoda@kfh-dialyse.de
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Marburg, Germany, 35043
- Not yet recruiting
- KfH Kidney Center for Children
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Contact:
- Nikola Jeck
- Phone Number: +49 6421 586 2650
- Email: jeckn@staff.uni-marburg.de
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Münster, Germany, 48149
- Not yet recruiting
- University Children's Hospital
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Contact:
- Martin Konrad, MD
- Email: konradma@uni-muenster.de
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Rostock, Germany, 18057
- Not yet recruiting
- Children's Hospital
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Contact:
- Marianne Wigger, MD
- Phone Number: +49 381 494 7158
- Email: marianne.wigger@med.uni-rostock.de
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Budapest, Hungary, 1083
- Not yet recruiting
- Semmelweis University
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Contact:
- Betti Schaefer, MD
- Phone Number: +36 13343186
- Email: bettus13@gmail.com
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Bologna, Italy, 40123
- Not yet recruiting
- S. Orsola-Malphighi Hospital
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Contact:
- Giovanni Montini, MD
- Phone Number: +39 6364617
- Email: giovanni.montini@aosp.bo.it
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Genova, Italy, 16147
- Not yet recruiting
- Istituto Giannina Gaslini
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Contact:
- Alberto Canepa, MD
- Phone Number: +39 010 5636275
- Email: albertocanepa@ospedale-gaslini.ge.it
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Milano, Italy, 20122
- Not yet recruiting
- Fondazione OSP Maggiore Policlinico
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Contact:
- Sara Testa, MD
- Phone Number: +39 0259032300
- Email: saratesta@tiscali.it
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Padova, Italy, 35128
- Not yet recruiting
- University of Padova
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Contact:
- Luisa Murer, MD
- Phone Number: +49 049 8213596
- Email: murer@pediatria.unipd.it
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Rome, Italy, 00163
- Not yet recruiting
- Bambino Gesu
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Contact:
- Chiara Matteucci, MD
- Email: matteucc@opbg.net
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Torino, Italy, 10126
- Not yet recruiting
- Regina Margherita Children's Hospital
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Contact:
- Licia Peruzzi, MD
- Phone Number: +39 0113131761
- Email: liciaperuzzi@hotmail.com
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Vilnius, Lithuania, 08406
- Not yet recruiting
- Vilnius University Children's Hospital
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Contact:
- Augustina Jankauskiene, MD
- Phone Number: +370 52720427
- Email: augustinajankauskiene@yahoo.com
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Gdansk, Poland, 80211
- Not yet recruiting
- Medical University Gdansk
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Contact:
- Aleksandra Zurowska, MD
- Phone Number: +48 601919335
- Email: azur@amq.qda.pl
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Krakow, Poland, 30-663
- Not yet recruiting
- University Children's Hospital
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Contact:
- Dorota Drozdz, MD
- Phone Number: +48 604 787415
- Email: dadrozdz@cm-uj.krakow.pl
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Szczecin, Poland, 71-344
- Not yet recruiting
- Clinic of Pediatrics
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Warsaw, Poland, 04-730
- Not yet recruiting
- Children's Memorial Health Institute
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Contact:
- Mieczyslaw Litwin, MD
- Phone Number: +48 228151603
- Email: m.liwin@czd.pl
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Contact:
- Anna Niemirska, MD
- Phone Number: +48 228151603
- Email: aniemirska@oz.pl
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Sub-Investigator:
- Mieczyslaw Litwin, MD
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Porto, Portugal, 4200
- Not yet recruiting
- Hospital Sao Joao
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Contact:
- Ana Teixeira, MD
- Email: anafteixeira@gmail.com
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Belgrade, Serbia, 11000
- Not yet recruiting
- University Children's Hospital
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Contact:
- Amira Peco-Antic, MD
- Phone Number: +381 64 328 9191
- Email: amira@udk.bg.ac.yu
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Stockholm, Sweden, 14186
- Not yet recruiting
- Karolinska University Hospital
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Contact:
- Rafael Krmar, MD
- Phone Number: +46 858581480
- Email: rafael.krmar@klinvet.ki.se
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Bern, Switzerland, 3010
- Not yet recruiting
- Inselspital
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Contact:
- Giacomo Simonetti, MD
- Email: giacomo.simonetti@insel.ch
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Zurich, Switzerland, 8032
- Not yet recruiting
- University Children's Hospital
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Contact:
- Guido Laube, MD
- Phone Number: +41 442667390
- Email: guido.laube@kispi.uzh.ch
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Adana, Turkey, 01330
- Recruiting
- Çukurova Üniversitesi
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Contact:
- Bayazit Aysun, MD
- Phone Number: +90 322 3386832
- Email: ayskar@cu.edu.tr
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Contact:
- Anarat Ali, MD
- Phone Number: +90 322 3386832
- Email: anarat@cu.edu.tr
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Sub-Investigator:
- Aysun Bayazit, MD
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Ankara, Turkey, 06100
- Not yet recruiting
- Ankara University of Medicine
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Contact:
- Fatos Yalcinkaya, MD
- Phone Number: +90 312 5956708
- Email: yalcinkaya@tr.net
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Ankara, Turkey, 06100
- Not yet recruiting
- Hacettepe Medical Faculty
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Contact:
- Ali Duzova, MD
- Phone Number: +90 3123051863
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Contact:
- Aysin Bakkaloglu, MD
- Phone Number: + 90 3123051863
- Email: aysin@hacettepe.edu.tr
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Sub-Investigator:
- Ali Duzova, MD
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Ankara, Turkey, 06500
- Not yet recruiting
- Gazi University Hospital
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Contact:
- Oguz Soylemezoglu, MD
- Phone Number: + 90 312 202 5202
- Email: oguzs@gazi.edu.tr
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Ankara, Turkey
- Not yet recruiting
- Baskent University, Faculty of Medicine
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Contact:
- Esra Baskin, MD
- Email: esrabaskin@yahoo.com
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Ankara, Turkey
- Not yet recruiting
- Diskapi Childrens Hospital
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Contact:
- Nilgun Cakar, MD
- Email: nilguncakar@hotmail.com
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Ankara, Turkey
- Not yet recruiting
- Sami Ulus Childrens Hospital
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Contact:
- Gulay Demircin, MD
- Email: gulaydemircin@hotmail.com
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Istanbul, Turkey, 34303
- Recruiting
- Cerrahpasa Tip Fakultesi
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Contact:
- Salim Caliskan, MD
- Phone Number: +90 532 212 1302
- Email: salimc@istanbul.edu.tr
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Istanbul, Turkey, 34360
- Not yet recruiting
- Istanbul Medical Faculty
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Contact:
- Sevinc Emre, MD
- Phone Number: +90 532 616 2569
- Email: semre@istanbul.edu.tr
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Istanbul, Turkey
- Not yet recruiting
- Bakirkoy Children's Hospital
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Contact:
- Nur Canpolat, MD
- Phone Number: +90 5324423590
- Email: ncanpolat2000@hotmail.com
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Istanbul, Turkey
- Not yet recruiting
- Goztepe Educational and Research Hospital
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Contact:
- Nurdan Yildiz, MD
- Phone Number: +90 506 2392539
- Email: nurdanyl@yahoo.com.tr
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Istanbul, Turkey
- Not yet recruiting
- Haseki Educational and Research Hospital
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Contact:
- Mahmut Civilibal, MD
- Phone Number: +90 532 242 8989
- Email: drcivilibal@hotmail.com
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Sub-Investigator:
- Mahmut Civilibal, MD
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Istanbul, Turkey
- Not yet recruiting
- Marmara University Medical Faculty
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Contact:
- Harika Alpay, MD
- Phone Number: +90 532 645 1515
- Email: dhtalpay@superonline.com
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Istanbul, Turkey
- Not yet recruiting
- Sisli Educational and Research Hospital
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Contact:
- Gul Ozcelik, MD
- Phone Number: +90 542 233 4626
- Email: ozcelik62@gmail.com
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Izmir, Turkey, 35100
- Not yet recruiting
- Ege University
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Contact:
- Betül Sözeri, MD
- Phone Number: +90 232390 1263
- Email: betulsozeri@yahoo.com
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Contact:
- Sevgi Mir, MD
- Phone Number: +90 232390 1001
- Email: sevgi.mir@ege.edu.tr
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Sub-Investigator:
- Betül Sözeri, MD
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London, United Kingdom, WC1N3JH
- Not yet recruiting
- Great Ormond Street Hospital
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Contact:
- Rukshana Shroff, MD
- Phone Number: +44 207 4059200
- Email: shrofr@gosh.nhs.uk
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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4C
Children with chronic kidney disease stage IIIb to V (GFR 10 to 45 ml/min/1.73m²)
at screening.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
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3 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
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3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Anticipated)
April 1, 2014
Study Completion (Anticipated)
April 1, 2014
Study Registration Dates
First Submitted
August 7, 2009
First Submitted That Met QC Criteria
January 11, 2010
First Posted (Estimate)
January 12, 2010
Study Record Updates
Last Update Posted (Estimate)
January 12, 2010
Last Update Submitted That Met QC Criteria
January 11, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Keywords
- Children
- cardiovascular disease
- chronic kidney disease
- pulse wave velocity
- arterial stiffness
- progression
- chronic renal failure
- carotid intima media thickness
- cardiovascular morbidity
- vasculopathy
- left ventricular hypertrophy
- augmentation index
- left ventricular cardiac function
- genetic risk factors
- cardiopathy
- whole genome analysis
- haplotype analysis
- SNP-screening
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-32/2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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