RecruitingNCT06542822

IRONHEART: Intravenous Iron in 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


Sponsor

University Hospital Southampton NHS Foundation Trust

Enrollment

16 participants

Start Date

Apr 15, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called IRONHEART) is testing whether giving iron through an IV drip can help people with a specific type of heart failure. Their heart is weakened not from a blocked artery but from another cause, and they also have low iron levels. **You may be eligible if...** - You are 18 or older and have heart failure with a weakened pumping ability (ejection fraction below 40%) - Your heart failure is not caused by blocked arteries (non-ischaemic) - You have low iron levels (transferrin saturation below 20%) - You have been on standard heart failure medications, including an SGLT2 inhibitor, for at least 4 weeks - Your heart failure symptoms are mild to moderate (NYHA Class I–III) **You may NOT be eligible if...** - Your heart failure is caused by blocked arteries - You have severe kidney disease (eGFR below 30) or need dialysis - You have atrial fibrillation or atrial flutter - Your symptoms are severely limiting (NYHA Class IV) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFerric derisomaltose

See group descriptions


Locations(1)

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, United Kingdom

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NCT06542822


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