Identification of Cardiovascular Risk Factors Linked to Renal Failure Progression - Tabular View

Tracking Information

First Received Date ^ICMJE

January 23, 2008

Last Updated Date

February 5, 2008

Start Date ^ICMJE

July 2007

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

description of osteoprotegerin levels according to chronic renal failure progression [ Time Frame: inclusion ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00608998 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

calcium score description according to chronic renal failure progression [ Time Frame: inclusion ] [ Designated as safety issue: No ]
osteoprotegerin description according to calcium score [ Time Frame: inclusion ] [ Designated as safety issue: No ]
relationship between cardiovascular risk factors and calcium score [ Time Frame: inclusion ] [ Designated as safety issue: No ]
relationship between cardiovascular risk factors and cardiovascular disease [ Time Frame: inclusion ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Identification of Cardiovascular Risk Factors Linked to Renal Failure Progression

Official Title ^ICMJE

Vascular Risk Factors and Coronary Calcifications in Chronic Renal Failure Patients: Identification of Specific Factors Linked to Renal Failure Progression

Brief Summary

The aim of this study is to appreciate the influence of renal failure progression on vasculopathy (coronary calcifications and left ventricular hypertrophy) and cardiovascular risk factors.

Detailed Description

The aim of this study is to appreciate the relationship between:

extension of coronary calcifications and chronic renal failure progression
extension of coronary calcifications and levels of osteoprotegerin (bone disease marker)
cardiovascular risk factors and coronary calcifications
cardiovascular risk factors and existence of cardiovascular diseases

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case-Only, Cross-Sectional

Condition ^ICMJE

Chronic Renal Failure

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

August 2010

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patient who has signed the written consent form
Patient aged > 18 and < 90 years
Chronic renal failure defined by glomerular filtration rate (GFR)
- group 1: GFR >90 mL/min with urinary biological abnormalities and GFR comprised between 90 and 60 mL/min
- group 2: GFR comprised between 60 and 30 mL/min
- group 3: GFR <30 mL/min but without dialysis therapy

Exclusion Criteria:

Chronic renal failure patient requiring dialysis therapy

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Bernard CANAUD, Pr

00 33 4 67 33 84 95

b-canaud@chu-montpellier.fr

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00608998

Responsible Party

Prof Bernard CANAUD, Centre Hospitalier Universitaire Montpellier France

Study ID Numbers ^ICMJE

UF 7853, PHRC regional 2005, CHU Montpellier, France

Study Sponsor ^ICMJE

University Hospital, Montpellier

Collaborators ^ICMJE

CHU Lapeyronie MONTPELLIER
CHU Arnaud de Villeneuve MONTPELLIER

Investigators ^ICMJE

Principal Investigator:	Bernard CANAUD, Pr	CHU Lapeyronie Montpellier France
Study Chair:	Jean-Paul CRISTOL, Pr	CHU Lapeyronie Montpellier France
Study Chair:	Hélène VERNHET, Pr	CHU Arnaud de Villeneuve Montpellier France
Study Chair:	Kada KLOUCHE, Dr	CHU Lapeyronie Montpellier France
Study Chair:	Hélène LERAY-MORAGUES, Dr	CHU Lapeyronie Montpellier France

Information Provided By

University Hospital, Montpellier

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP