Actively Recruiting

Age: 18Years - 85Years
All Genders
ID05356325

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

Led by Maimónides Biomedical Research Institute of Córdoba · Updated on 2025-02-07

401

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Maimónides Biomedical Research Institute of Córdoba

Lead Sponsor

F

Fondo de Investigacion Sanitaria

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the link between anemia caused by iron deficiency and cardiovascular damage, especially in people with or without chronic kidney disease (CKD). The study focuses on a protein called fibroblast growth factor 23 (FGF23), which has been linked to heart problems. They aim to understand how anemia affects FGF23 levels and cardiovascular health, and to identify possible ways to prevent or reduce heart damage. The project includes several parts: examining blood samples from patients with iron deficiency anemia with and without CKD; studying effects in animal models including rats with anemia and CKD; and testing different intravenous iron treatments to see how they affect FGF23 levels and heart health. The study also looks at how certain drugs might influence these processes and investigates the direct effects of FGF23 on heart cells in lab cultures. Participants will provide blood samples before starting iron treatment and again after 12 months. Researchers will measure various blood markers related to iron, kidney function, heart damage, and inflammation. Advanced techniques will analyze gene and protein profiles linked to the condition. The study will monitor heart health indicators and biochemical measurements over time to understand the relationship between anemia, FGF23, and cardiovascular damage.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Hemoglobin less than 11 g/dl
  • Serum ferritin less than 100 ng/ml or transferrin saturation index less than 20%
  • Age between 18 and 85 years
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Weight less than 50 kg or BMI less than 17
  • Acute bleeding greater than 500 ml within 72 hours before study inclusion
  • Proliferative hematologic disease or hemochromatosis
  • Active infections within 30 days before study inclusion
  • Systemic inflammatory illness
  • HIV, Hepatitis B, or Hepatitis C infection
  • Receiving active iron treatment or blood transfusion in the last 90 days
  • Cardiovascular hospitalization within 30 days before study inclusion
  • Anticoagulant treatment with coumarins
  • Chronic liver disease
  • Immunosuppressive therapy
  • Treatment with erythropoiesis stimulating agents, radiotherapy, or chemotherapy within 30 days before inclusion
  • Scheduled major surgery during study period
  • Pregnancy or lactation
  • Drug addiction
  • Participation in other clinical trials

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Sample Collection

Duration - 12 months

Participants provide blood samples at the start and 12 months after beginning iron supplementation to analyze various biochemical and molecular parameters related to anemia and kidney function.

2 visits (in-person)

Long-term Monitoring

Duration - Up to 12 months or until study completion

Participants are observed to evaluate the effects of iron supplementation and related changes on cardiovascular damage and other health markers over time.

Visits at baseline and 12 months for blood sampling; additional assessments may occur as needed

Trial Site Locations

Total: 1 location

1

Hospital Universitario Reina Sofia

Córdoba, Spain, 14004

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Research Team

C

Casimiro Valle Domínguez, MD

A

Alejandro Martín-Malo, PhD, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Differences between intravenous iron products: focus on treatment of iron deficiency in chronic heart failure patients.

Alejandro Martin-Malo, Gerrit Borchard, Beat Flühmann...

https://pubmed.ncbi.nlm.nih.gov/30694615

Fibroblast growth factor 23 predicts carotid atherosclerosis in individuals without kidney disease. The CORDIOPREV study.

Maria E Rodríguez-Ortiz, Juan F Alcalá-Díaz, Antonio Canalejo...

https://pubmed.ncbi.nlm.nih.gov/31899053

Serum Magnesium is associated with Carotid Atherosclerosis in patients with high cardiovascular risk (CORDIOPREV Study).

M Encarnación Rodríguez-Ortiz, Francisco Gómez-Delgado, Antonio P Arenas de Larriva...

https://pubmed.ncbi.nlm.nih.gov/31142774

Inflammation both increases and causes resistance to FGF23 in normal and uremic rats.

Maria E Rodríguez-Ortiz, Juan M Díaz-Tocados, Juan R Muñoz-Castañeda...

https://pubmed.ncbi.nlm.nih.gov/31860056