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

NCT ID: NCT03307707

Last Updated: 2017-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-15

Study Completion Date

2015-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Kidney Disease, Chronic Heart Failure

Keywords

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FGF23 klotho Mineral Bone Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Heart Failure (HF)

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

No interventions assigned to this group

No Heart Failure (NHF)

subjects with LVEF\>50%

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Early CKD stage
* Heart failure

Exclusion Criteria

* Infections
* cancer
* corticoid therapy
* renal replacement therapy
* Advanced CKD stage
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pr. Semir Nouira

OTHER

Sponsor Role lead

Responsible Party

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Pr. Semir Nouira

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lamti Feten, PhD student

Role: STUDY_CHAIR

Research Laboratory (LR12SP18) University of Monastir Tunisia, Tunisia and Research Unit (UR17ES29) Faculty of Pharmacy , Monastir

Other Identifiers

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CKD-MBD-HF

Identifier Type: -

Identifier Source: org_study_id