New Heart Failure Biomarkers in Early Stage Chronic Kidne... | NCT03307707

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

NCT03307707

Sponsor

Pr. Semir Nouira

Status

Completed

Last Update Posted

Oct 12, 2017Actual

Enrollment

111Actual

Phase

Not provided

Conditions

Kidney Disease, Chronic
Heart Failure

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2015Actual

Primary Completion Date

Sep 30, 2015Actual

Completion Date

Dec 30, 2015Actual

First Submitted Date

Oct 4, 2017

First Submission Date that Met QC Criteria

Oct 5, 2017

First Posted Date

Oct 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2017

Last Update Posted Date

Oct 12, 2017Actual

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

111Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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%

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Early CKD stage
Heart failure

Exclusion Criteria:

Infections
cancer
corticoid therapy
renal replacement therapy
Advanced CKD stage

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D006333	Heart Failure

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided