The Prevalence of Iron Deficiency and the Effectiveness of Ferinject® in Patients With HFpEF (ID-HFpEF)
Recruiting · NCT05793996 · Interventional (participants receive a specific treatment) · Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
View the official record on ClinicalTrials.gov →Interventions studied
Diet therapyFerinject
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences - Tomsk, Russia