IRONHEART: Intravenous Iron in Non-ischaemic Heart Failure

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 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

Conditions3

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