Examining iron deficiency treatment in heart failure patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the prevalence of iron deficiency in patients with heart failure with preserved ejection fraction (HFpEF) and evaluates the effectiveness of intravenous ferric carboxymaltose (Ferinject®) in improving quality of life and functional status. It involves a randomized controlled design where patients with symptomatic chronic heart failure (NYHA II-III) will receive treatment and be compared to a control group without iron deficiency. The study aims to gather data on how correcting iron deficiency impacts the clinical course of HFpEF.

Why it matters

Who can join: the full rules

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's running

• Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
  Tomsk, Russia Recruiting

Study contacts

• Principal investigator: Alla A. Garganeeva, M.D. — Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
• Study coordinator: Olga V. Tukish, Ph.D.
• Email: olgatukish@yandex.ru
• Phone: +79069476343

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.