New Heart Failure Biomarkers in Early Stage Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD-HF)

October 5, 2017 updated by: Pr. Semir Nouira

Heart Failure and Early Stage Chronic Kidney Disease -Mineral Bone Disorder : the Importance of the New Biomarkers

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

111

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 to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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 .

Description

Inclusion Criteria:

  • Early CKD stage
  • Heart failure

Exclusion Criteria:

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

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
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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fibroblast Growth Factor 23 (FGF23)
Time Frame: completed data base (after 4 months)
compare the circulating levels of FGF23 (pg/ml) in the two groups .
completed data base (after 4 months)
Alpha Klotho
Time Frame: completed data base (after 4 months)
compare the circulating levels of klotho (ng/ml) in the two groups .
completed data base (after 4 months)

Collaborators and Investigators

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

Sponsor

Pr. Semir Nouira

Investigators

  • Study Chair: Lamti Feten, PhD student, Research Laboratory (LR12SP18) University of Monastir Tunisia, Tunisia and Research Unit (UR17ES29) Faculty of Pharmacy , Monastir

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 (ACTUAL)

June 15, 2015

Primary Completion (ACTUAL)

September 30, 2015

Study Completion (ACTUAL)

December 30, 2015

Study Registration Dates

First Submitted

October 4, 2017

First Submitted That Met QC Criteria

October 5, 2017

First Posted (ACTUAL)

October 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 12, 2017

Last Update Submitted That Met QC Criteria

October 5, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CKD-MBD-HF

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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