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
Tomsk National Research Medical Center of the Russian Academy of Sciences
100 participants
Apr 28, 2023
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
Inclusion Criteria5
- 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 Criteria13
- 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.
Interventions
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.
Patients will receive diet therapy to correct latent iron deficiency
Locations(1)
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NCT05793996