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

Heart Failure Clinical Trial

— CKD-MBD-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03307707
• Other study ID #: CKD-MBD-HF
• Status: Completed
• Phase: N/A
• First received: October 4, 2017
• Last updated: October 5, 2017
• Start date: June 15, 2015
• Est. completion date: December 30, 2015

Study information

• Verified date: October 2017
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: December 30, 2015
• Est. primary completion date: September 30, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Early CKD stage

• Heart failure

Exclusion Criteria:

• Infections

• cancer

• corticoid therapy

• renal replacement therapy

• Advanced CKD stage

Related Conditions & MeSH terms

• Bone Diseases
• Chronic Disease
• Chronic Kidney Disease-Mineral and Bone Disorder
• Heart Failure
• Kidney Disease, Chronic
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pr. Semir Nouira

Outcome

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