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Could a simple iron shot boost energy in heart failure?

NCT ID NCT05793996

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

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

    RECRUITING

    Tomsk, 634012, Russia

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