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

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

Inclusion Criteria:

* Signed informed consent to participate in the study;
* In New York Heart Association (NYHA) II-III functional class due to stable symptomatic chronic heart failure (CHF);
* Left ventricular ejection fraction (LVEF) ≥50%; objective signs of structural and/or functional disorders of the heart consistent with the presence of LV diastolic dysfunction/increased LV filling pressure, including elevated levels of natriuretic peptide;
* Screening ferritin below 100 µg/L, or below 300 µg/L when transferrin saturation (TSAT) is below 20%;
* Screening haemoglobin (Hb) at the time of switching on ( 90-150 g/l).

Exclusion Criteria:

* Uncontrolled arterial hypertension;
* Аnemia not related to iron deficiency;
* Аnemia with a hemoglobin level of less than 90 g/l;
* Less than 1 year after acute myocardial infarction;
* Less than 1 year after acute cerebral circulation disorder;
* Less than 1 year after surgical interventions, including non-cardiac operations and myocardial revascularization (coronary bypass surgery, coronary artery stenting), operations for valvular pathology;
* Chronic alcoholism (including alcoholic heart disease), mental disorders;
* Severe hepatic (increased transaminase levels above the upper three limits of normal) and renal insufficiency (glomerular filtration rate less than 15 ml/min/1.73 m2);
* Known active infection, clinically significant bleeding, active malignancy;
* Severe autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc.);
* Severe bronchial asthma, COPD in the acute stage;
* Allergic reactions to medications in the anamnesis, eczema, atopic allergic reaction;
* Blood transfusions and taking erythropoiesis-stimulating drugs during the previous three months.

Conditions3

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