IRONHEART: Intravenous Iron in Non-ischaemic Heart Failure (NCT06542822) | Clinical Trial Compass
RecruitingNot Applicable
IRONHEART: Intravenous Iron in Non-ischaemic Heart Failure
United Kingdom16 participantsStarted 2024-04-15
Plain-language summary
The aim of this study is to observe the effect of intravenous ferric derisomaltose in participants with non-ischaemic heart failure (LVEF\<40%), iron deficiency (TSATS\<20%) and established on heart failure therapy including Sodium-glucose cotransporter 2 inhibitors (SGLT2i). Participants will undergo baseline laboratory blood tests, cardiac magnetic resonance imaging (cMRI), six-minute walk test, musculoskeletal function test and Kansas City Cardiomyopathy Questionnaire (KCCQ). These investigations will be repeated at 24 hours and 30 days after the administration of intravenous ferric derisomaltose.
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:
* Participants capable of giving informed consent.
* Aged 18yrs and above.
* Diagnosed with heart failure and a reduction of their ejection fraction \< 40% by any modality.
* Non ischaemic cardiomyopathy as determined by baseline cardiac magnetic resonance imaging.
* Iron deficient per this definition: Transferrin saturations \< 20%.
* Established on Heart failure therapy including SGLT2i therapy for a minimum of four weeks prior to recruitment.
* New York Heart Association score of I - III class.
Exclusion Criteria:
* New York Heart Association classification Score \>IV
* Ischaemic cardiomyopathy
* Chronic kidney stage: Estimated Glomerular Filtration Rate (eGFR) \< 30
* Requirement for renal dialysis
* Atrial fibrillation / atrial flutter
* Non cardiac and cardiac palliative diagnosis
* Active cancer diagnosis
* Moderate to severe valvular heart disease
* Cardiac electronic implantable device: Cardiac resynchronization therapy, Implantable cardioverter-defibrillator, left ventricular assist device
* Cardiac \& non cardiac transplant participants
* Myocardial infarction, Percutaneous Coronary Intervention, Coronary Artery Bypass Graft surgery in the last 30 days
* Complex congenital heart disease
* Pregnancy
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Ejection Fraction quantified on Cardiac Magnetic Resonance Imaging
Timeframe: 24 Hours and 30 days
Trial details
NCT IDNCT06542822
SponsorUniversity Hospital Southampton NHS Foundation Trust