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Identification of Cardiovascular Risk Factors Linked to Renal Failure Progression (Pre-HD)
This study is currently recruiting participants.
Verified by University Hospital, Montpellier, January 2008
Sponsors and Collaborators: University Hospital, Montpellier
CHU Lapeyronie MONTPELLIER
CHU Arnaud de Villeneuve MONTPELLIER
Information provided by: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT00608998
  Purpose

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.


Condition
Chronic Renal Failure

MedlinePlus related topics: Kidney Failure
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Cross-Sectional
Official Title: Vascular Risk Factors and Coronary Calcifications in Chronic Renal Failure Patients: Identification of Specific Factors Linked to Renal Failure Progression

Further study details as provided by University Hospital, Montpellier:

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

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

whole blood white cells serum plasma urine


Estimated Enrollment: 120
Study Start Date: July 2007
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00608998

Contacts
Contact: Bernard CANAUD, Pr 00 33 4 67 33 84 95 b-canaud@chu-montpellier.fr

Locations
France
Centre Hospitalier Universitaire Recruiting
Montpellier, France, 34295
Contact: Bernard CANAUD, Pr     00 33 4 67 33 84 95     b-canaud@chu-montpellier.fr    
Principal Investigator: Bernard CANAUD, Pr            
Sub-Investigator: Jean-Paul CRISTOL, Pr            
Sub-Investigator: Hélène VERNHET, Pr            
Sub-Investigator: Kada KLOUCHE, Dr            
Sub-Investigator: Hélène LERAY-MORAGUES, Dr            
Sponsors and Collaborators
University Hospital, Montpellier
CHU Lapeyronie MONTPELLIER
CHU Arnaud de Villeneuve MONTPELLIER
Investigators
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
  More Information

Responsible Party: Centre Hospitalier Universitaire Montpellier France ( Prof Bernard CANAUD )
Study ID Numbers: UF 7853, PHRC regional 2005, CHU Montpellier, France
Study First Received: January 23, 2008
Last Updated: February 5, 2008
ClinicalTrials.gov Identifier: NCT00608998  
Health Authority: France: Direction Générale de la Santé

Keywords provided by University Hospital, Montpellier:
Chronic renal failure
Vasculopathy
Cardiovascular risk
Chronic renal failure patients

Study placed in the following topic categories:
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Disease Progression
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on January 16, 2009