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

Fibroblast Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01154842
• Other study ID #: 1-perk
• Status: Active, not recruiting
• Phase: N/A
• First received: June 30, 2010
• Last updated: July 12, 2010
• Start date: December 2009
• Est. completion date: June 2010

Study information

• Verified date: January 2010
• Source: Diskapi Teaching and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 128
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult hemodialysis patients (age>18 years old)

Exclusion Criteria:

• Malignancy, active infection

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Fibroblast

Locations

Country	Name	City	State
Turkey	Diskapi Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		7 months	No