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
  Purpose

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
Fibroblast

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Diskapi Teaching and Research Hospital:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Human plasma to measure FGF-23 levels


Enrollment: 128
Study Start Date: December 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hemodialysis
Adult hemodialysis patients (age>18 years)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01154842

Locations
Turkey
Diskapi Training and Research Hospital
Ankara, Turkey
Sponsors and Collaborators
Diskapi Teaching and Research Hospital
Investigators
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

No publications provided

Responsible Party: Diskapi Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01154842     History of Changes
Other Study ID Numbers: 1-perk
Study First Received: June 30, 2010
Last Updated: July 12, 2010
Health Authority: Turkey: Ethics Committee

Keywords provided by Diskapi Teaching and Research Hospital:
FGF-23
Dialysis
plasma FGF-23 levels
echocardiography

Additional relevant MeSH terms:
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014