Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542822
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-02
Brief Title:
IRONHEART Intravenous Iron in Non-ischaemic Heart Failure
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IRONHEART
Brief Summary:
The aim of this study is to observe the effect of intravenous ferric derisomaltose in participants with non-ischaemic heart failure LVEF40 iron deficiency TSATS20 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
Detailed Description:
Heart failure is a neuro-endocrine syndrome in which patients report symptoms of breathlessness and lethargy accompanied with signs of fluid overload
Iron deficiency is very common in heart failure affecting up to 50 of patients Its presence in this population is associated with worsening symptoms and increased risk of death Human clinical trials have shown that administering intravenous iron improves quality of life and exercise tolerance The European Society Guidelines gives a 1A class recommendation for intravenous iron replacement in symptomatic heart failure patients
Iron is an essential micro-nutrient required in mitochondrial metabolism handling of reactive oxygen species and cellular metabolism Heart failure leads to a pro inflammatory state resulting in reduced gastrointestinal absorption and inhibition of iron mobilisation Mouse models have shown reversal of cardiac fibrosis cardiac remodelling and reduction in the pro inflammatory state when treated with intravenous iron Similarly iron deficient human cardiomyocytes show adverse remodelling and altered function reversed with iron repletion
The investigators aim to recruit 16 participants with non-ischaemic heart failure established on optimal medical therapy including SGLT2i therapy for four weeks prior to the start of the trial Initial baseline investigations will include cMRI six-minute walk test hand grip strength test laboratory blood tests and a KCCQ-12 Intravenous ferric derisomaltose will be given as standard of care These investigations will be repeated at 24 hours and at 30 days after the administration of intravenous ferric derisomaltose
The study aims to observe changes pre and post administration of intravenous derisomaltose in the following
Changes in cardiac function and parametric measurements T1T2 as assessed by cardiac magnetic resonance imaging
Changes in high sensitivity troponin N Terminal pro-Brain Natriuretic Peptide NT pro-BNP and serum phosphate levels
Changes in the submaximal exercise test six-minute walk and musculoskeletal function test hand grip test
Changes in heart failure symptoms as assessed by KCCQ Questionnaire
Iron deficiency is very common in heart failure affecting up to 50 of patients Its presence in this population is associated with worsening symptoms and increased risk of death Human clinical trials have shown that administering intravenous iron improves quality of life and exercise tolerance The European Society Guidelines gives a 1A class recommendation for intravenous iron replacement in symptomatic heart failure patients
Iron is an essential micro-nutrient required in mitochondrial metabolism handling of reactive oxygen species and cellular metabolism Heart failure leads to a pro inflammatory state resulting in reduced gastrointestinal absorption and inhibition of iron mobilisation Mouse models have shown reversal of cardiac fibrosis cardiac remodelling and reduction in the pro inflammatory state when treated with intravenous iron Similarly iron deficient human cardiomyocytes show adverse remodelling and altered function reversed with iron repletion
The investigators aim to recruit 16 participants with non-ischaemic heart failure established on optimal medical therapy including SGLT2i therapy for four weeks prior to the start of the trial Initial baseline investigations will include cMRI six-minute walk test hand grip strength test laboratory blood tests and a KCCQ-12 Intravenous ferric derisomaltose will be given as standard of care These investigations will be repeated at 24 hours and at 30 days after the administration of intravenous ferric derisomaltose
The study aims to observe changes pre and post administration of intravenous derisomaltose in the following
Changes in cardiac function and parametric measurements T1T2 as assessed by cardiac magnetic resonance imaging
Changes in high sensitivity troponin N Terminal pro-Brain Natriuretic Peptide NT pro-BNP and serum phosphate levels
Changes in the submaximal exercise test six-minute walk and musculoskeletal function test hand grip test
Changes in heart failure symptoms as assessed by KCCQ Questionnaire
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None