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

July 12, 2010 updated by: Diskapi Teaching and Research Hospital

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Actual)

128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey
        • Diskapi Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult hemodialysis patients (age>18 years old)

Description

Inclusion Criteria:

  • Adult hemodialysis patients (age>18 years old)

Exclusion Criteria:

  • Malignancy, active infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Anticipated)

May 1, 2010

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

June 30, 2010

First Submitted That Met QC Criteria

June 30, 2010

First Posted (Estimate)

July 1, 2010

Study Record Updates

Last Update Posted (Estimate)

July 14, 2010

Last Update Submitted That Met QC Criteria

July 12, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • 1-perk

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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