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
This trial does not accept healthy volunteersQualifiers
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 population
Participants with non-ischaemic cardiomyopathy with a left ventricular function less than 40% and iron deficient as per the following criteria: Transferrin saturations \< 20%
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ferric derisomaltose
DrugSee group descriptions
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: IRONHEART Observational Study Group1 intervention
Trial outcomes
Primary outcomes
1
Ejection Fraction quantified on Cardiac Magnetic Resonance Imaging
Changes in Ejection Fraction quoted in (%)
Time frame
24 Hours and 30 daysSecondary outcomes
1
T1 Mapping quantified on Cardiac Magnetic Resonance Imaging
Changes in T1 Parametric Mapping quantified in (msec)
Time frame
24 Hours and 30 days2
T2 Mapping quantified on Cardiac Magnetic Resonance Imaging
Changes in T2 Parametric Mapping quantified in (msec)
Time frame
24 Hours and 30 Days3
Extracellular Volume (ECV) Fraction quantified on Cardiac Magnetic Resonance Imaging
Changes in ECV Fraction quoted in (%)
Time frame
24 Hours and 30 Days4
Ventricular Volumes quantified on Cardiac Magnetic Resonance Imaging
Changes in left and right ventricular volumes quantified in (ml)
Time frame
24 Hours and 30 DaysSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Southampton NHS Foundation Trust
Lead sponsor
Portsmouth Hospitals NHS Trust
Collaborator
Source ClinicalTrials.gov