NCT06542822 IRONHEART: Intravenous Iron in Non-ischaemic Heart Failure
| NCT ID | NCT06542822 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Southampton NHS Foundation Trust |
| Condition | Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 16 participants |
| Start Date | 2024-04-15 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 16 participants in total. It began in 2024-04-15 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility 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
Contact & Investigator
Andrew S Flett, MBBS BSc MD
PRINCIPAL INVESTIGATOR
University Hospital Southampton NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT06542822 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06542822 currently recruiting?
Yes, NCT06542822 is actively recruiting participants. Contact the research team at andrew.flett@uhs.nhs.uk for enrollment information.
Where is the NCT06542822 trial being conducted?
This trial is being conducted at Southampton, United Kingdom.
Who is sponsoring the NCT06542822 clinical trial?
NCT06542822 is sponsored by University Hospital Southampton NHS Foundation Trust. The principal investigator is Andrew S Flett, MBBS BSc MD at University Hospital Southampton NHS Foundation Trust. The trial plans to enroll 16 participants.
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