IRONHEART: Intravenous Iron in Non-ischaemic Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ferric derisomaltose.
- Who it may be relevant to
- Registry conditions: Heart Failure, Iron Deficiencies. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Immediate Effects of Intravenous Iron Therapy in Patients With Systolic Heart Failure and Iron Deficiency as Evaluated by Cardiac Magnetic Resonance Imaging: An Observational Prospective Study
Overview
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.
Detailed description
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.
Interventions
- Drug Ferric derisomaltose
See group descriptions
Primary outcome measures
- Ejection Fraction quantified on Cardiac Magnetic Resonance Imaging [Time frame: 24 Hours and 30 days]
Secondary outcome measures (12)
- T1 Mapping quantified on Cardiac Magnetic Resonance Imaging [Time frame: 24 Hours and 30 days]
- T2 Mapping quantified on Cardiac Magnetic Resonance Imaging [Time frame: 24 Hours and 30 Days]
- Extracellular Volume (ECV) Fraction quantified on Cardiac Magnetic Resonance Imaging [Time frame: 24 Hours and 30 Days]
- Ventricular Volumes quantified on Cardiac Magnetic Resonance Imaging [Time frame: 24 Hours and 30 Days]
- Indexed Ventricular Volume quantified on Cardiac Magnetic Resonance Imaging [Time frame: 24 Hours and 30 Days]
- Strain analysis as quantified on Cardiac Magnetic Resonance Imaging [Time frame: 24 Hours and 30 Days]
- Quality of Life assessment: KCCQ-12 questionnaire [Time frame: 24 Hours and 30 Days]
- Submaximal Exercise Test: Six Minute Walk Test [Time frame: 24 Hours and 30 Days]
- Musculoskeletal function test: Hand grip test [Time frame: 24 Hours and 30 Days]
- Haemoglobin [Time frame: 30 Days]
- High Sensitivity troponin [Time frame: 24 Hours and 30 Days]
- Phosphate [Time frame: 24 Hours and 30 Days]
Eligibility criteria
Inclusion criteria
- 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.
- New York Heart Association score of I - III class.
Exclusion criteria
- 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
- Active cancer diagnosis
- Moderate to severe valvular heart disease
- Cardiac electronic implantable device: Cardiac resynchronization therapy, Implantable cardioverter-defibrillator, left ventricular assist device
- Cardiac \& non cardiac transplant participants
- Myocardial infarction, Percutaneous Coronary Intervention, Coronary Artery Bypass Graft surgery in the last 30 days
- Complex congenital heart disease
- Pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- University Hospital Southampton NHS Foundation Trust — Southampton
Identifiers
NCT: NCT06542822 · RHMCAR0640