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

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Conditions studied: Fibroblast Growth Factor 23, Anemia, CKD

In brief

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.

Key facts

Study ID

NCT05356325

Run by

Maimónides Biomedical Research Institute of Córdoba

People needed

401

Starts

2021-10-18

Expected to finish

2025-07-01

Last updated by the study team

2025-02-07

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Hemoglobin < 11g/dl
• Serum ferritin < 100 ng/ml or transferrin saturation index < 20%

You may not qualify if…

• Weight < 50 Kg or BMI < 17
• Acute bleeding > 500 ml, within 72 hours before study inclusion
• Proliferative hematologic disease. Hemochromatosis
• Active infections within 30 days before study inclusion
• Systemic inflammatory illness
• Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) or Hepatitis B virus (HBV) infection
• Iron active treatment
• Blood transfusion in the last 90 days before inclusion.
• Cardiovascular hospitalization 30 days before study inclusion
• Anticoagulant treatment with coumarins
• Chronic liver disease
• Immunosuppressive therapy
• Erythropoiesis stimulating agents treatment, radiotherapy or chemiotherapy within 30 days before inclusion
• Scheduled major surgery during study period
• Pregnancy or lactation
• Drugs addiction
• Participation in others clinical trials.

Where it is running

• Hospital Universitario Reina Sofia — Córdoba, Spain (enrolling)

Full record on ClinicalTrials.gov

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