Examining iron deficiency treatment in heart failure patients

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

This study tests if treating iron deficiency with a specific medication can help improve the quality of life and daily functioning for people with heart failure.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences (other)
• Locations: 1 site (Tomsk)
• Trial ID: NCT05793996 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients with stable symptomatic chronic heart failure (NYHA II-III) and documented iron deficiency.

Not a fit: Patients with anemia not related to iron deficiency or those with uncontrolled hypertension may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with HFpEF by addressing iron deficiency.

How similar studies have performed: Other studies have shown promising results in treating iron deficiency in heart failure patients, suggesting this approach may be effective.

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.

Where this trial is running

Tomsk

• 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.

Conditions: Chronic Heart Failure, Iron Deficiency, Latent, HFpEF, iron deficiency, ferric carboxymaltose, Ferinject