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

Tomsk National Research Medical Center of the Russian Academy of Sciences

Status and phase: Enrolling; Phase 4

Conditions: Chronic Heart Failure; Iron Deficiency, Latent

Treatments: Other: Diet therapy; Drug: Ferinject

Study type: Interventional

Funder types: Other

Identifiers

NCT05793996

ID-HFpEF

Details and patient eligibility

About

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.

Full description

The prevalence of HFpEF among patients admitted to cardiology hospitals will be studied. The study will include patients with NYHA II-III who have signed an informed consent that meets the inclusion/exclusion criteria. The effectiveness of intravenous administration of iron carboxymaltose (Ferinject ® ) to correct iron deficiency and improve the clinical course of HFpEF will be evaluated. A group without iron deficiency will be recruited as a control group (n=30).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 3 patient groups

Experimental: 1

Active Comparator group

Description:

Drug: Ferinject ® (Ferric carboxymaltose)

Treatment:

Drug: Ferinject

Comparison Group: 2

Other group

Description:

Diet therapy, without drug therapy

Treatment:

Other: Diet therapy

Control Group: 3

No Intervention group

Description:

Without therapy