NCT01154842

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2010

Completed
Last Updated

July 14, 2010

Status Verified

January 1, 2010

Enrollment Period

5 months

First QC Date

June 30, 2010

Last Update Submit

July 12, 2010

Conditions

Fibroblast

Keywords

FGF-23Dialysisplasma FGF-23 levelsechocardiography

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Hemodialysis

Adult hemodialysis patients (age\>18 years)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult hemodialysis patients (age\>18 years old)

You may qualify if:

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

You may not qualify if:

  • Malignancy, active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Human plasma to measure FGF-23 levels

Study Officials

  • 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 CHAIR

  • DENIZ AYLI, Assoc Prof

    Diskapi Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2010

First Posted

July 1, 2010

Study Start

December 1, 2009

Primary Completion

May 1, 2010

Study Completion

June 1, 2010

Last Updated

July 14, 2010

Record last verified: 2010-01

Locations

TU(1)