Observes how iron given by infusion affects the heart in heart failure
Observes iron infusion effects in adults with heart failure and iron deficiency.
Plain-language title generated from the registry record
Registry title: IRONHEART: Intravenous Iron in Non-ischaemic Heart Failure
Key facts
- Where
- Southampton, United KingdomSee the site
Where in United Kingdom
- University Hospital Southampton NHS Foundation TrustSouthampton, United KingdomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital Southampton NHS Foundation Trust
- Trial code
- NCT06542822
- Record updated
- 7 August 2024
- Original description
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.Read full original descriptionShow less
Immediate Effects of Intravenous Iron Therapy in Patients With Systolic Heart Failure and Iron Deficiency as Evaluated by Cardiac Magnetic Resonance Imaging: An Observational Prospective Study
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.
Inclusion: 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: New York Heart Association classification Score >IV; 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; Chronic kidney stage: Estimated Glomerular Filtration Rate (eGFR) < 30; Ischaemic cardiomyopathy; Requirement for renal dialysis; Atrial fibrillation / atrial flutter; Pregnancy.