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

Launched by TOMSK NATIONAL RESEARCH MEDICAL CENTER OF THE RUSSIAN ACADEMY OF SCIENCES · Mar 30, 2023

Keywords

ClinConnect Summary

This clinical trial, called ID-HFpEF, is looking at how common iron deficiency is in patients with a specific type of heart failure called HFpEF (Heart Failure with preserved Ejection Fraction) and whether treating this deficiency with a medication called Ferinject® can improve their quality of life and overall health. The study is currently recruiting participants, particularly those aged 65 to 74, and is open to all genders. To join the trial, participants need to have stable heart failure symptoms, a specific heart function measurement (ejection fraction of 50% or more), and low levels of iron in their body.

Eligible participants will receive treatment to help correct their iron deficiency, and the effects of this treatment on their daily life and physical ability will be closely monitored. It’s important to note that certain health conditions may exclude someone from participating, such as uncontrolled high blood pressure, severe anemia not caused by iron deficiency, or recent major health events like heart attacks or strokes. This trial aims to provide more insight into the relationship between iron levels and heart health, which could lead to better care for patients with heart failure in the future.

Gender

ALL

Eligibility 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 ( 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.