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Could a daily iron pill boost energy in heart failure?

NCT ID NCT06270498

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a daily oral iron supplement (sucrosomial iron with vitamin C) can improve exercise ability and quality of life in people with chronic heart failure and iron deficiency. About 60 participants will receive either the iron supplement or a placebo for 24 weeks. Researchers will measure changes in a six-minute walk test and a heart failure symptom questionnaire.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sucrosomial iron (a type of iron supplement with vitamin C)
What this could lead to
If it works, this could offer a simple oral supplement to help heart failure patients feel better and walk farther.
What could go wrong
This is a small, early-phase trial with only 60 participants, so results may not apply broadly. Iron supplements can cause stomach upset or constipation.

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 60 people

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

Started

Mar 2024

Expected to finish

Jun 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: 1. Chronic HF (New York Heart Association \[NYHA\] functional class II-IV) patients, on optimal therapy, and clinically stable for at least 4 weeks with no dose changes of HF drugs 2. LVEF\<50% at screening visit (historical value can be used if performed within 6 months of screening visit) 3. Either a documented hospitalization for HF in the previous 12 months of enrolment or an elevated NT-proBNP: ≥250 pg/mL (or BNP ≥75 pg/mL) for patients in normal sinus rhythm; ≥1,000 pg/mL (or BNP ≥400 pg/mL) for patients in atrial fibrillation 4. TSAT \<20% 5. Hemoglobin 10.0-16.0 g/dL 6. Rapid iron repletion with intravenous iron is not considered a clinical necessity by physicians after reviewing patient medical record (if anaemia is present, its grade is no more than mild) 7. Age ≥18 years, male and female 8. Willingness to provide informed consent 9. Subjects who decide to use single or dual contraceptive methods to avoid conceiving during the study period Exclusion Criteria: 1. Neuromuscular, orthopedic or other non-cardiac condition that prevents the patient from exercise testing 2. Exercise training program in the previous 3 months, or planned in the next 3 months 3. Recent (\<3 month) acute coronary syndrome, coronary artery bypass surgery, percutaneous coronary interventions, transient ischemic attack, or stroke 4. Severe valvular disease, hypertrophic obstructive cardiomyopathy, restrictive or constrictive cardiomyopathy, acute myocarditis 5. Atrial fibrillation or flutter with a ventricular response rate of \&gt;100 beats per minute at rest 6. Temperature ≤38 °C (oral or equivalent) or active infection as defined by current use of oral or intravenous antimicrobial agents 7. Need for blood transfusion within the last month 8. Hb\<10 g/dL or Hb\>16 g/dL 9. Rapid iron repletion with intravenous iron is considered a clinical necessity by physicians after reviewing patient medical record 10. Documented active gastrointestinal bleeding 11. Oral iron, i.v. iron or erythropoietin stimulating agent within the last 3 months 12. eGFR ≤15 mL/min or on hemodialysis 13. Chronic liver disease and/or alanine transaminase or aspartate transaminase above 3 times the upper limit of the normal range 14. Active cancer 15. Evidence of iron overload (ferritin \>400 ng/mL) 16. Hypersensitivity to any of the study products or known severe allergies 17. Participation in another study 18. Low body weight (≤35 kg) 19. Known or anticipated pregnancy in the next 4 months 20. Need for forbidden medications 21. Breastfeeding 22. Consumption of iron-rich foods or any food that alter iron absorption (i.e. food rich in vitamin C) due to dietary requirements 23. Any pathological condition or disease associated with a reduction or an impairment of intestinal iron absorption (i.e., prior gastrectomy, atrophic gastritis, bariatric surgery, coeliac disease)

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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.

  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.

    Open the record ↗

  3. 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

  • Azienda Ospedaliero Universitaria Pisana

    RECRUITING

    Pisa, Tuscany, 56124, Italy

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