Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGPhase 4INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Signed willing to sign a consent form 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). Who Should NOT Join This Trial: - 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 conditions (where your immune system attacks your own body)s (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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Ferinject

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.

OTHER

Diet 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