Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsN/A

IRONHEART: Intravenous Iron in Non-ischaemic Heart Failure

Sponsor: University Hospital Southampton NHS Foundation Trust

NCT ID: NCT06542822

View on ClinicalTrials.gov ↗

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.

Heart FailureIron Deficiencies

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

eGFR

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
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

Where Is This Study? (1 UK site)

University Hospital Southampton NHS Foundation Trust

Southampton SO16 6YD, United Kingdom

Recruiting
Site contact (verified)
Andrew S Flett, MBBS BSc MD+442381205906andrew.flett@uhs.nhs.uk

How to Get in Touch

Flett

Sponsor contact

CONTACT

+442381205906 andrew.flett@uhs.nhs.uk

Rachael Pulham

Sponsor contact

CONTACT

+442381205044 sponsor@uhs.nhs.uk
Data sourced from ClinicalTrials.gov · Last verified: 2024-08