RecruitingNCT05356325

FGF23 and Cardiovascular Damage in Anemia With an Without Chronic Kidney Disease.

The Role of FGF23 on the Induction of Cardiovascular Damage in Anemia With an Without Chronic Kidney Disease


Sponsor

Maimónides Biomedical Research Institute of Córdoba

Enrollment

401 participants

Start Date

Oct 18, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

Anemia is associated with cardiovascular disease. Iron deficiency is usually induced in chronic kidney disease (CKD). In clinical studies, an inverse association between serum levels of iron and fibroblast growth factor 23 (FGF23), a cardiovascular risk factor, has been demonstrated. In addition, a number of the I.V. iron presentations mostly used to treat anemia show unwanted side effects related to phosphate alterations and increased FGF23. Objectives. The General Objective of this project is to evaluate, through in vivo and in vitro studies, the cardiovascular alterations related to the anemia-induced increase in FGF23 production; as well as the identification of possible molecular targets that may be useful in its prevention and/or palliation. Specific Objectives are: 1) To determine in a population with anemia (due to iron deficiency), with and without CKD, an association between the parameters related to iron metabolism, FGF23 and markers of cardiovascular damage. 2) To evaluate in vivo, in a murine experimental model of anemia, with and without CKD, the effects of the modulation (inhibition) of triggers of iron deficiency (hepcidin) and of the increase in FGF23 (HF1α), on markers of cardiovascular damage. 3) To compare in vivo, in an experimental model of anemia with and without CKD, the effect of different I.V. iron presentations (ferrous sulphate, ferric carboxymaltose and ferric citrate) on FGF23 levels and their cardiovascular impact. 4) To evaluate in vitro, in cardiomyocytes cultures, in the presence of iron deficiency, the direct effect of FGF23 on the induction of cardiac damage. 5) To evaluate in vitro, in osteoblasts cultures, the direct effect of ferrous sulphate, ferric carboxymaltose, ferric citrate and hepcidin. Methodology. The levels of intact and C-terminal FGF23 (FGF23i and FGF23c), the differential expression profile of plasma miRNAS and of proteomic, markers of cardiovascular disease, mineral metabolism, inflammation and oxidative stress and intracellular signalling pathways will be evaluated.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating a protein called FGF23 and how it relates to heart and blood vessel damage in people with anemia (low red blood cell levels), both with and without chronic kidney disease (CKD). The goal is to better understand why people with anemia and kidney disease are at increased risk for heart problems. **You may be eligible if...** - You have anemia, defined as hemoglobin below 11 g/dL - Your iron stores are low (ferritin below 100 ng/mL or transferrin saturation below 20%) **You may NOT be eligible if...** - Your weight is under 50 kg or your BMI is below 17 - You have had significant blood loss (over 500 mL) in the past 72 hours - You have a blood cancer or hemochromatosis (iron overload disease) - You have an active infection or inflammatory disease in the past 30 days - You are receiving iron supplements, blood transfusions recently, or treatments like erythropoietin, chemotherapy, or radiotherapy - You are pregnant or breastfeeding - You have chronic liver disease, HIV, hepatitis B or C, or are on anticoagulants (blood thinners of the coumarin type) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Hospital Universitario Reina Sofia

Córdoba, Spain

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NCT05356325


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