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Fibroblast Growth Factor-23 (FGF-23) is Independently Associated With Left Ventricular Mass Index (LVMI) and Myocardial Performance Index (MPI) in Haemodialysis Patients

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ClinicalTrials.gov Identifier: NCT01154842
Recruitment Status : Unknown
Verified January 2010 by Diskapi Teaching and Research Hospital.
Recruitment status was:  Active, not recruiting
First Posted : July 1, 2010
Last Update Posted : July 14, 2010
Sponsor:
Information provided by:
Diskapi Teaching and Research Hospital

Study Description
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Brief Summary:
Serum FGF-23 levels will be measured in patients with a history of coronary artery disease and aortic valve calcifications.It will be searched whether patients with MPI>0.47 had higher or lower serum FGF-23 levels than those with MPI<0.47. Correlations will be examined between log FGF-23 levels and LVMI and MPI. Uni and Multivariable-adjusted regression analyses regarding whether increased log FGF-23 concentrations are independently associated with increased left ventricular mass index and increased MPI, will be performed.

Condition or disease
Fibroblast

Detailed Description:

Fibroblast growth factor 23 (FGF-23) is a phosphorus-regulating substance. Circulating FGF-23 levels increase markedly in dialysis patients and are independently associated with increased risk of mortality. Given the fact that cardiovascular disease is the leading cause of death in dialysis patients, the aim of this study was to test if elevated FGF-23 levels might be associated with left ventricular mass index (LVMI) and left ventricular index of myocardial performance (MPI) in maintenance haemodialysis patients.

Methods: In this cross-sectional study, plasma FGF-23 concentrations are measured using a C-terminal human enzyme-linked immunosorbent assay kit and echocardiography is performed in maintenance haemodialysis patients.

Serum FGF-23 levels will be measured in patients with a history of coronary artery disease and aortic valve calcifications.It will be searched whether patients with MPI>0.47 had higher or lower serum FGF-23 levels than those with MPI<0.47. Correlations will be examined between log FGF-23 levels and LVMI and MPI. Uni and Multivariable-adjusted regression analyses regarding whether increased log FGF-23 concentrations are independently associated with increased left ventricular mass index and increased MPI, will be performed.

Study Design
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Study Type : Observational
Actual Enrollment : 128 participants
Time Perspective: Cross-Sectional
Official Title: Serum Fibroblast Growth Factor-23 (FGF-23) Levels Are Independently Associated With Left Ventricular Mass and Myocardial Performance Index in Maintenance Haemodialysis Patients
Study Start Date : December 2009
Estimated Primary Completion Date : May 2010
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Groups and Cohorts
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Group/Cohort
Hemodialysis
Adult hemodialysis patients (age>18 years)


Outcome Measures
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Primary Outcome Measures :
  1. To test if elevated FGF-23 levels might be associated with left ventricular mass index (LVMI) and left ventricular index of myocardial performance (MPI) in maintenance haemodialysis patients. [ Time Frame: 7 months ]

Biospecimen Retention:   Samples With DNA
Human plasma to measure FGF-23 levels

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult hemodialysis patients (age>18 years old)
Criteria

Inclusion Criteria:

  • Adult hemodialysis patients (age>18 years old)

Exclusion Criteria:

  • Malignancy, active infection
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154842


Locations
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Turkey
Diskapi Training and Research Hospital
Ankara, Turkey
Sponsors and Collaborators
Diskapi Teaching and Research Hospital
Investigators
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Study Chair: ALPER KIRKPANTUR, Assoc Prof Diskapi Training and Research Hospital
Study Chair: MUSTAFA BALCI, Dr Diskapi Training and Research Hospital
Study Chair: OGUZ GURBUZ, Dr Diskapi Training and Research Hospital
Study Chair: BARIS AFSAR, Dr Zonguldak Training and Research Hospital
Study Chair: BASOL CANBAKAN, Assoc Prof Diskapi Training and Research Hospital
Study Chair: RAMAZAN AKDEMIR, Assoc Prof Diskapi Training and Research Hospital
Study Director: DENIZ AYLI, Assoc Prof Diskapi Training and Research Hospital
More Information
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Responsible Party: Diskapi Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01154842    
Other Study ID Numbers: 1-perk
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: July 14, 2010
Last Verified: January 2010
Keywords provided by Diskapi Teaching and Research Hospital:
FGF-23
Dialysis
plasma FGF-23 levels
echocardiography