Actively Recruiting

Age: 18Years +
All Genders
NCT06542822

IRONHEART: Intravenous Iron in Non-ischaemic Heart Failure

Led by University Hospital Southampton NHS Foundation Trust · Updated on 2024-08-07

16

Participants Needed

1

Research Sites

146 weeks

Total Duration

On this page

Sponsors

U

University Hospital Southampton NHS Foundation Trust

Lead Sponsor

P

Portsmouth Hospitals NHS Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

IRONHEART: Intravenous Iron in Non-ischaemic Heart Failure

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants capable of giving informed consent.
  • Aged 18 years and above.
  • Diagnosed with heart failure and a reduction of ejection fraction below 40% by any modality.
  • Non-ischaemic cardiomyopathy confirmed by baseline cardiac magnetic resonance imaging.
  • Iron deficiency defined as transferrin saturation below 20%.
  • On heart failure therapy including SGLT2 inhibitor therapy for at least four weeks prior to recruitment.
  • New York Heart Association (NYHA) class I to III.
Not Eligible

You will not qualify if you...

  • New York Heart Association classification score greater than IV.
  • Ischaemic cardiomyopathy.
  • Chronic kidney disease with estimated glomerular filtration rate (eGFR) below 30.
  • Requirement for renal dialysis.
  • Atrial fibrillation or atrial flutter.
  • Non-cardiac and cardiac palliative diagnosis.
  • Active cancer diagnosis.
  • Moderate to severe valvular heart disease.
  • Cardiac electronic implantable devices such as cardiac resynchronization therapy, implantable cardioverter-defibrillator, or left ventricular assist device.
  • Cardiac or non-cardiac transplant recipients.
  • Myocardial infarction, percutaneous coronary intervention, or coronary artery bypass graft surgery within the last 30 days.
  • Complex congenital heart disease.
  • Pregnancy.

AI-Screening

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Trial Site Locations

Total: 1 location

1

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, United Kingdom, SO16 6YD

Actively Recruiting

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Research Team

F

Flett

CONTACT

R

Rachael Pulham

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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