Could a simple iron shot boost energy in heart failure?
NCT ID NCT05793996
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether giving intravenous iron (Ferinject) to heart failure patients with low iron can improve their quality of life and walking ability. About 100 hospitalized adults with a specific type of heart failure (HFpEF) will receive either iron infusions plus diet advice or diet advice alone. The goal is to see if the iron group scores higher on heart failure questionnaires and walks farther in six minutes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ferinject (ferric carboxymaltose, an intravenous iron supplement)
- What this could lead to
- If it works, this could point toward a simple iron infusion to improve daily life and physical function for people with heart failure and low iron.
- What could go wrong
- This is a small, early-phase study (100 people) and may not show meaningful benefit. Iron infusions carry rare risks like allergic reactions or iron overload.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
RECRUITINGTomsk, 634012, Russia
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