NCT06542822
IRONHEART: Intravenous Iron in Non-ischaemic Heart Failure
Recruiting · Not specified · University Hospital Southampton NHS Foundation Trust · registry updated 2024-08-07
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Exclusion
- 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