At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Ferric derisomaltose (drug)
- How long the study runs
- Study runs about 34 months (dates as stated)
- About the drug or intervention
- Ferric derisomaltose — drug: See group descriptions
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 16
- Started
- 2024-04-15
- Last checked
- 2024-08
Plain English Summary
What is this study?
- • Testing a new treatment for heart failure
- • Clinical study - 16 participants
- • 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)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with heart failure
Where?
- • Southampton - University Hospital Southampton NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Participants capable of giving agreement to take part.
- ✓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 heart magnetic resonance imaging.
- ✓Iron deficient per this definition: Transferrin saturations \< 20%.
Who cannot take part
- ✗New York Heart Association classification Score \>IV
- ✗Ischaemic cardiomyopathy
- ✗Chronic kidney stage: Estimated Glomerular Filtration Rate (eGFR) \< 30
- ✗Requirement for kidney dialysis
- ✗Atrial fibrillation / atrial flutter
See the full criteria
Where Is This Study? (1 UK site)
University Hospital Southampton NHS Foundation Trust
Southampton SO16 6YD, United Kingdom
How to Get in Touch
Flett
Sponsor contactCONTACT
Rachael Pulham
Sponsor contactCONTACT
