Sponsor study identifier
observational
16
1 country
1
Study Start
April 15, 2024
Actual (reported)Primary Completion
February 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 15, 2024
Actual (reported)July 2, 2024
Actual (reported)August 7, 2024
Actual (reported)February 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Ejection Fraction quantified on Cardiac Magnetic Resonance Imaging
Changes in Ejection Fraction quoted in (%)
24 Hours and 30 days
T1 Mapping quantified on Cardiac Magnetic Resonance Imaging
24 Hours and 30 days
T2 Mapping quantified on Cardiac Magnetic Resonance Imaging
24 Hours and 30 Days
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.
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Participants with non-ischaemic cardiomyopathy with a left ventricular function less than 40% and iron deficient as per the following criteria: Transferrin saturations \< 20%
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD, United Kingdom
Andrew S Flett, MBBS BSc MD
University Hospital Southampton NHS Foundation Trust
First Submitted
July 2, 2024
First Posted
August 7, 2024
Study Start
April 15, 2024
Actual (reported)Primary Completion
February 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Extracellular Volume (ECV) Fraction quantified on Cardiac Magnetic Resonance Imaging
24 Hours and 30 Days
Ventricular Volumes quantified on Cardiac Magnetic Resonance Imaging
24 Hours and 30 Days
Indexed Ventricular Volume quantified on Cardiac Magnetic Resonance Imaging
24 Hours and 30 Days
Contact the study team to confirm eligibility.
Study Completion
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 7, 2024
Record last verified: 2024-08
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Source: ClinicalTrials.gov.
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