Clinical trial NCT01154842: Fibroblast Growth Factor-23 (FGF-23) is Independently Associated With Left Ventricular Mass Index (LVMI) and Myocardial Performance Index (MPI) in Haemodialysis Patients
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fibroblast
Keywords: FGF-23
Dialysis
plasma FGF-23 levels
echocardiography
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2010-07-01
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult hemodialysis patients (age\>18 years old)

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.

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.

Eligibility criteria: Inclusion Criteria:

* Adult hemodialysis patients (age\>18 years old)

Exclusion Criteria:

* Malignancy, active infection

Primary outcomes:
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.
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Training and Research Hospital
Study officials:
affiliation: Diskapi Training and Research Hospital
name: ALPER KIRKPANTUR, Assoc Prof
role: STUDY_CHAIR
affiliation: Diskapi Training and Research Hospital
name: MUSTAFA BALCI, Dr
role: STUDY_CHAIR
affiliation: Diskapi Training and Research Hospital
name: OGUZ GURBUZ, Dr
role: STUDY_CHAIR
affiliation: Zonguldak Training and Research Hospital
name: BARIS AFSAR, Dr
role: STUDY_CHAIR
affiliation: Diskapi Training and Research Hospital
name: BASOL CANBAKAN, Assoc Prof
role: STUDY_CHAIR
affiliation: Diskapi Training and Research Hospital
name: RAMAZAN AKDEMIR, Assoc Prof
role: STUDY_CHAIR
affiliation: Diskapi Training and Research Hospital
name: DENIZ AYLI, Assoc Prof
role: STUDY_DIRECTOR
References: