The purpose of this study is to determine whether intravenous iron supplementation using ferric carboxymaltosis (FCM) extends the time-to-first-event of heart failure hospitalisations and cardiovascular (CV) death and reduces hospitalisation and mortality in patients with iron deficiency and heart failure.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with chronic HFrEF (CHF) of at least 3 months duration and a history of documented LVEF\<45%.
. Confirmed presence of ID (ferritin \< 100 ng/mL or ferritin 100 - 299 ng/mL with TSAT \< 20 %)
. Serum haemoglobin of 9.5 - 14.0 g/dL
. At time of screening considered re-stabilised and planned for discharge within next 24 h (NYHA 2 or 3), or stable ambulatory with a HF hospitalisation in the past 12 months (NYHA 2-4), or stable ambulatory with BNP \> 100 pg/mL or NT-proBNP \> 300 pg/mL or MR-proANP \> 120 pmol/L (NYHA 2-4)
. Written informed consent
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested intravenous iron specifically in people with systolic heart failure and iron deficiency — does my diagnosis match both of those conditions, and is my iron deficiency confirmed with the kind of blood tests they used, like a transferrin saturation below 20%?
2The trial tracked CV death and heart failure hospitalizations as its main outcomes — based on my current situation, does my doctor think intravenous iron could realistically affect my risk of being hospitalized or having a serious heart event, or is the evidence still uncertain?
3Since this was a Phase 4 trial, meaning it was studying an already-approved treatment in a real-world population, what does my doctor think the completed results tell us about whether IV iron is something I should be considering now as part of my standard care?
4The trial paid special attention to patients with a transferrin saturation under 20% — does my lab work fall into that range, and does that change how strongly my doctor would recommend IV iron for me specifically?
5Are there standard treatments for systolic heart failure and iron deficiency that my doctor would want me to try first, or is IV iron something that would be used alongside my current medications rather than instead of them?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time-to-first event of CV death or HF hospitalisation
Timeframe: The whole follow-up period. We aim for a minimum average follow-up of >2 years. We aim for a minimum follow-up of 6 months for all patients, but not less than 3 months.
2
Rate of total (first and recurrent) events of hospitalisations for heart failure (HF)
Timeframe: The wohle follow-up period. We aim for a minimum average follow-up of >2 years. We aim for a minimum follow-up of 6 months for all patients, but not less than 3 months.
3
Time-to-first event of CV death or HF hospitalisation in patients with TSAT <20%
Timeframe: During the wohle follow-up period. We aim for a minimum average follow-up of >2 years. We aim for a minimum follow-up of 6 months for all patients, but not less than 3 months.