Status:
RECRUITING
IRONHEART: Intravenous Iron in Non-ischaemic Heart Failure
Lead Sponsor:
University Hospital Southampton NHS Foundation Trust
Collaborating Sponsors:
Portsmouth Hospitals NHS Trust
Conditions:
Heart Failure
Iron Deficiencies
Eligibility:
All Genders
18+ years
Brief Summary
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 f...
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06542822
Start Date
April 15 2024
End Date
February 1 2027
Last Update
August 7 2024
Active Locations (1)
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1
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD