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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
Other Locations
United Kingdom
University Hospital Southampton NHS Foundation Trust
RECRUITING
Southampton
Contact Information
Primary
Flett
andrew.flett@uhs.nhs.uk
+442381205906
Backup
Rachael Pulham
sponsor@uhs.nhs.uk
+442381205044
Time Frame
Start Date: 2024-04-15
Estimated Completion Date: 2027-02
Participants
Target number of participants: 16
Treatments
IRONHEART Observational Study Group
16 participants, with non-ischaemic heart failure, with iron deficiency TSATS \<20% and heart failure with a reduced ejection fraction \<40%.~Cohort will have to be established on guideline directed heart failure therapy. Participants meeting eligibility criteria will undergo baseline quality of life questionnaires, hand grip tests and six minute walk tests before receiving intravenous iron derisomaltose and repeating these investigations again after 24 hours and 30 days including a cardiac magnetic resonance imaging.
Related Therapeutic Areas
Sponsors
Leads: University Hospital Southampton NHS Foundation Trust
Collaborators: Portsmouth Hospitals NHS Trust

This content was sourced from clinicaltrials.gov

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