Intravenous iron treatment for patients with non-ischaemic heart failure
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
This study tests whether an intravenous iron treatment can help people with non-ischaemic heart failure and iron deficiency feel better while they are already on heart failure medications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Southampton NHS Foundation Trust Academic / other |
| Locations | 1 site (Southampton, Hampshire) |
| Trial ID | NCT06542822 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effects of intravenous ferric derisomaltose on patients with non-ischaemic heart failure and iron deficiency. Participants will undergo a series of baseline assessments, including laboratory tests, cardiac imaging, and functional tests, before receiving the treatment. Follow-up assessments will be conducted at 24 hours and 30 days post-treatment to monitor changes in their condition. The study focuses on patients who are already on heart failure therapy, including SGLT2 inhibitors, to ensure optimal management.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with non-ischaemic heart failure and iron deficiency, specifically those with an ejection fraction less than 40%.
Not a fit: Patients with ischaemic cardiomyopathy, severe heart failure (NYHA class IV), or significant renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life and exercise capacity for patients suffering from non-ischaemic heart failure and iron deficiency.
How similar studies have performed: Previous studies have shown that intravenous iron can improve symptoms and outcomes in heart failure patients, supporting the potential effectiveness of this approach.
Eligibility criteria
Show full inclusion / exclusion 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 this trial is running
Southampton, Hampshire
- University Hospital Southampton NHS Foundation Trust — Southampton, Hampshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Andrew S Flett, MBBS BSc MD — University Hospital Southampton NHS Foundation Trust
- Study coordinator: Flett
- Email: andrew.flett@uhs.nhs.uk
- Phone: +442381205906
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.