Could a daily iron pill boost energy in heart failure?
NCT ID NCT06270498
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
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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 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Jun 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: 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 \>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.
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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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Azienda Ospedaliero Universitaria Pisana
RECRUITINGPisa, Tuscany, 56124, Italy
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- Can GLP-1 drugs improve heart function during exercise in Obesity-Related heart failure?
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- Fine-Tuning heart failure drugs to flush out excess salt
- A supplement that could help heart failure patients shed excess fluid?