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CompletedNCT03307707CKD-MBD-HFUpdated Oct 12, 2017

New Heart Failure Biomarkers in Early Stage Chronic Kidney Disease-Mineral and Bone Disorder

An observational study in Kidney Disease, Chronic and Heart Failure, sponsored by Pr. Semir Nouira. Completed. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-12.

Sponsored by Pr. Semir Nouira · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
111
Ages
18 Years to 90 Years
Sex
All
01

Study summary

the objective of this study is to :

-Determinate wether the circulating levels of iFGF23 and klotho can be a predictor biomarker of HF in patients with CKD-MBD.

Read the detailed description

The disorders of mineral metabolism and bone disease are common complications in CKD patients and they are associated with increased morbidity and mortality.

Abnormalities of the vasculature are seen in early CKD, producing vascular stiffness contributing to left ventricular hypertrophy and its pathophysiology involves newly discovered hormones, such as the fibroblast Growth factor 23 (FGF23) and α- klotho.

The FGF receptor and its co-receptor klotho moderate these effects. FGF23 levels inflate early in in the advancement of CKD stage to attain levels in CKD stage 5D.

But we still have few knoweledges if these markers can have some drawbacks for predicting CVD in early stage CKD.

02

Conditions studied

  • Kidney Disease, Chronic
  • Heart Failure

Keywords

  • FGF23
  • klotho
  • Mineral Bone Disorder
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

subjects who visited the emmergency departement or the nephrology departement , meeting the criteria inclusion and have given a written consent .

Inclusion criteria

  • Early CKD stage
  • Heart failure

Exclusion criteria

Exclusion Criteria:

  • Infections
  • cancer
  • corticoid therapy
  • renal replacement therapy
  • Advanced CKD stage
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
111 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Heart Failure (HF)

    subjects with a Left Ventricular Ejection Fraction (LVEF) \<50% or LVEF \>50% and E/e'\>10.

  • No Heart Failure (NHF)

    subjects with LVEF\>50%

05

What researchers measure

Primary outcomes

  1. Fibroblast Growth Factor 23 (FGF23)

    compare the circulating levels of FGF23 (pg/ml) in the two groups .

    Time frame: completed data base (after 4 months)

  2. Alpha Klotho

    compare the circulating levels of klotho (ng/ml) in the two groups .

    Time frame: completed data base (after 4 months)

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03307707
Lead sponsor
Pr. Semir Nouira
Responsible party
Pr. Semir Nouira (Professor, University of Monastir) — Sponsor-investigator
First posted
Oct 12, 2017
Start date
Jun 15, 2015
Primary completion
Sep 30, 2015
Completion
Dec 30, 2015
Last update
Oct 12, 2017

Study contacts

Lamti Feten, PhD student
study chair · Research Laboratory (LR12SP18) University of Monastir Tunisia, Tunisia and Research Unit (UR17ES29) Faculty of Pharmacy , Monastir
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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