IRONHEART: Intravenous Iron in Non-ischaemic Heart Failure
NCT Number: NCT06542822
Acronym: IRONHEART
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Heart Failure|Iron Deficiencies
Interventions: DRUG: Ferric derisomaltose
Sponsor: University Hospital Southampton NHS Foundation Trust
Collaborators: Portsmouth Hospitals NHS Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-15
Completion Date: 2027-02
Locations: University Hospital Southampton NHS Foundation Trust, Southampton, Hampshire, SO16 6YD, United Kingdom

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.

Primary Outcome Measures: Ejection Fraction quantified on Cardiac Magnetic Resonance Imaging, Changes in Ejection Fraction quoted in (%), 24 Hours and 30 days
Secondary Outcome Measures: T1 Mapping quantified on Cardiac Magnetic Resonance Imaging, Changes in T1 Parametric Mapping quantified in (msec), 24 Hours and 30 days|T2 Mapping quantified on Cardiac Magnetic Resonance Imaging, Changes in T2 Parametric Mapping quantified in (msec), 24 Hours and 30 Days|Extracellular Volume (ECV) Fraction quantified on Cardiac Magnetic Resonance Imaging, Changes in ECV Fraction quoted in (%), 24 Hours and 30 Days|Ventricular Volumes quantified on Cardiac Magnetic Resonance Imaging, Changes in left and right ventricular volumes quantified in (ml), 24 Hours and 30 Days|Indexed Ventricular Volume quantified on Cardiac Magnetic Resonance Imaging, Changes in indexed left and right ventricular volumes. Weight and Height will be combined to calculate Body Surface Area (m2). Left Ventricular Volume in (ml) will be divided by Body Surface Area to give indexed value (ml/m2), 24 Hours and 30 Days|Strain analysis as quantified on Cardiac Magnetic Resonance Imaging, Changes in strain as assessed by feature tracking on cardiac magnetic resonance imaging, 24 Hours and 30 Days|Quality of Life assessment: KCCQ-12 questionnaire, Changes in Kansas City Cardiomyopathy Questionnaire. Four sub-domains: Physical limitation, Symptom Frequency, Quality of life and social limitations. Scores range from 0 - 100, with higher scores reflecting a better heart status., 24 Hours and 30 Days|Submaximal Exercise Test: Six Minute Walk Test, Changes in distance walked (meters) in six minutes, 24 Hours and 30 Days|Musculoskeletal function test: Hand grip test, Changes in Isometric Grip Force in (KG), 24 Hours and 30 Days|Haemoglobin, Laboratory Blood Test, 30 Days|High Sensitivity troponin, Laboratory Blood Test, 24 Hours and 30 Days|Phosphate, Laboratory Blood Test, 24 Hours and 30 Days|N-terminal pro B type natriuretic peptide (NTproBNP), Laboratory Blood Test, 30 Days