IRONHEART: Intravenous Iron in Non-ischaemic Heart Failure
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
University Hospital Southampton NHS Foundation Trust
16 participants
Apr 15, 2024
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria13
- 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
Interventions
See group descriptions
Locations(1)
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NCT06542822