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OpenTrials
Completed

NCT Number: NCT03307707

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

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.

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Key information

Conditions

Kidney Disease, Chronic Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Early CKD stage
  • Heart failure

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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 .

  2. Alpha Klotho

    Time frame: completed data base (after 4 months)

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

Sponsors and collaborators

Lead sponsor

Pr. Semir Nouira

Other

Registry information

Official study title

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

Acronym: CKD-MBD-HF

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 12, 2017
Registry last updated
Oct 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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