IRONHEART: Intravenous Iron in Non-ischaemic Heart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Southampton NHS Foundation Trust
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
New York Heart Association classification Score >IV
Ischaemic cardiomyopathy
Chronic kidney stage: Estimated Glomerular Filtration Rate (eGFR) < 30
Requirement for renal dialysis
Trial design
Treatments tested in this trial
- Ferric derisomaltose
Treatment groups
16 Participants
are divided into 1 treatment groupSponsors and collaborators
University Hospital Southampton NHS Foundation Trust
Lead sponsor
Portsmouth Hospitals NHS Trust
Collaborator
Source ClinicalTrials.gov