Actively Recruiting
The Prevalence of Iron Deficiency and the Effectiveness of Ferinject® in Patients With HFpEF (ID-HFpEF)
Led by Tomsk National Research Medical Center of the Russian Academy of Sciences · Updated on 2025-12-16
100
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
The Prevalence of Iron Deficiency and the Effectiveness of Ferinject® in Patients With HFpEF (ID-HFpEF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent to participate in the study
- New York Heart Association (NYHA) II-III functional class due to stable symptomatic chronic heart failure
- Left ventricular ejection fraction (LVEF) 6550%; signs of structural or functional heart disorders consistent with LV diastolic dysfunction or increased LV filling pressure, including elevated natriuretic peptide levels
- Screening ferritin below 100 g/L, or below 300 g/L when transferrin saturation (TSAT) is below 20%
- Screening hemoglobin (Hb) between 90 and 150 g/l at the time of enrollment
You will not qualify if you...
- Uncontrolled arterial hypertension
- Anemia not related to iron deficiency
- Anemia with hemoglobin level 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), or operations for valvular pathology
- Chronic alcoholism including alcoholic heart disease, mental disorders
- Severe hepatic insufficiency (transaminase levels above three times upper normal limit) 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 such as systemic lupus erythematosus, rheumatoid arthritis
- Severe bronchial asthma or COPD in acute stage
- History of allergic reactions to medications, eczema, or atopic allergic reactions
- Blood transfusions or use of erythropoiesis-stimulating drugs in the previous three months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Tomsk, Russia, 634012
Actively Recruiting
Research Team
O
Olga V. Tukish, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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