RecruitingPhase 4NCT05793996

The Prevalence of Iron Deficiency and the Effectiveness of Ferinject® in Patients With HFpEF (ID-HFpEF)

Study of the Prevalence of Iron Deficiency Among Hospitalized Patients With HFpEF and the Impact of Ferinject® on Indicators of Quality of Life, Functional Status in Patients With Iron Deficiency


Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Enrollment

100 participants

Start Date

Apr 28, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Observational cohort randomized controlled study to study the influence of correction of ID by intravenous injection of ferric carboxymaltose (Ferinject®) on quality of life indicators, functional status in a cohort of patients with HFpEF.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how common iron deficiency is in patients with a specific type of heart failure where the heart's pumping function is preserved (called HFpEF), and whether an iron infusion (Ferinject) helps improve symptoms. **You may be eligible if...** - You have stable, symptomatic chronic heart failure with a preserved pumping function (ejection fraction of 50% or more) - Your heart failure symptoms are rated moderate to severe (NYHA class II-III) - You have signs of iron deficiency: ferritin below 100, or ferritin 100–299 with low transferrin saturation (under 20%) - You have elevated levels of a heart stress marker (natriuretic peptide) - You have signed informed consent **You may NOT be eligible if...** - You have iron levels above the required threshold - You have certain other heart or blood conditions your doctor will review 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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Interventions

DRUGFerinject

The calculation of the dose of iron carboxymaltosate (Ferinject ® preparation) for the purpose of correction of iron will be carried out on the basis of the following step-by-step approach: determination of individual iron needs, calculation and administration of iron dose, assessment of the saturation of the patient's body with iron 6 weeks after infusion.

OTHERDiet therapy

Patients will receive diet therapy to correct latent iron deficiency


Locations(1)

Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences

Tomsk, Russia

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NCT05793996


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