IRONHEART: Intravenous Iron in Non-ischaemic Heart Failure

Heart failure is a neuro-endocrine syndrome in which patients report symptoms of breathlessness and lethargy accompanied with signs of fluid overload.

Iron deficiency is very common in heart failure, affecting up to 50% of patients. Its presence in this population is associated with worsening symptoms and increased risk of death. Human clinical trials have shown that administering intravenous iron improves quality of life and exercise tolerance. The European Society Guidelines gives a 1A class recommendation for intravenous iron replacement in symptomatic heart failure patients.

Iron is an essential micro-nutrient required in mitochondrial metabolism, handling of reactive oxygen species and cellular metabolism. Heart failure leads to a pro inflammatory state, resulting in reduced gastrointestinal absorption, and inhibition of iron mobilisation. Mouse models have shown reversal of cardiac fibrosis, cardiac remodelling, and reduction in the pro inflammatory state when treated with intravenous iron. Similarly iron deficient human cardiomyocytes show adverse remodelling and altered function reversed with iron repletion.

The investigators aim to recruit 16 participants with non-ischaemic heart failure, established on optimal medical therapy, including SGLT2i therapy, for four weeks prior to the start of the trial. Initial baseline investigations will include: cMRI, six-minute walk test, hand grip strength test, laboratory blood tests and a KCCQ-12. Intravenous ferric derisomaltose will be given as standard of care. These investigations will be repeated at 24 hours and at 30 days after the administration of intravenous ferric derisomaltose.

The study aims to observe changes pre and post administration of intravenous derisomaltose in the following:

* Changes in cardiac function and parametric measurements (T1/T2) as assessed by cardiac magnetic resonance imaging. * Changes in high sensitivity troponin, N Terminal pro-Brain Natriuretic Peptide (NT pro-BNP) and serum phosphate levels. * Changes in the submaximal exercise test (six-minute walk) and musculoskeletal function test (hand grip test). * Changes in heart failure symptoms as assessed by KCCQ Questionnaire.

• T1 Mapping quantified on Cardiac Magnetic Resonance Imaging [Срок оценки: 24 Hours and 30 days]
• T2 Mapping quantified on Cardiac Magnetic Resonance Imaging [Срок оценки: 24 Hours and 30 Days]
• Extracellular Volume (ECV) Fraction quantified on Cardiac Magnetic Resonance Imaging [Срок оценки: 24 Hours and 30 Days]
• Ventricular Volumes quantified on Cardiac Magnetic Resonance Imaging [Срок оценки: 24 Hours and 30 Days]
• Indexed Ventricular Volume quantified on Cardiac Magnetic Resonance Imaging [Срок оценки: 24 Hours and 30 Days]
• Strain analysis as quantified on Cardiac Magnetic Resonance Imaging [Срок оценки: 24 Hours and 30 Days]
• Quality of Life assessment: KCCQ-12 questionnaire [Срок оценки: 24 Hours and 30 Days]
• Submaximal Exercise Test: Six Minute Walk Test [Срок оценки: 24 Hours and 30 Days]
• Musculoskeletal function test: Hand grip test [Срок оценки: 24 Hours and 30 Days]
• Haemoglobin [Срок оценки: 30 Days]
• High Sensitivity troponin [Срок оценки: 24 Hours and 30 Days]
• Phosphate [Срок оценки: 24 Hours and 30 Days]