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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Diskapi Teaching and Research Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier:
NCT01154842
First received: June 30, 2010
Last updated: July 12, 2010
Last verified: January 2010

June 30, 2010
July 12, 2010
December 2009
May 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01154842 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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
Serum Fibroblast Growth Factor-23 (FGF-23) Levels Are Independently Associated With Left Ventricular Mass and Myocardial Performance Index 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.

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.

Observational
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Human plasma to measure FGF-23 levels

Non-Probability Sample

Adult hemodialysis patients (age>18 years old)

Fibroblast
Not Provided
Hemodialysis
Adult hemodialysis patients (age>18 years)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
128
June 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult hemodialysis patients (age>18 years old)

Exclusion Criteria:

  • Malignancy, active infection
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT01154842
1-perk
Yes
Diskapi Training and Research Hospital
Diskapi Teaching and Research Hospital
Not Provided
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
Diskapi Teaching and Research Hospital
January 2010

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