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

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences

Criteria

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 (in women >120 g/l, in men >130 g/l).

Exclusion Criteria:

• Uncontrolled arterial hypertension;

• Anemia;

• 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.