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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Ejection Fraction quantified on Cardiac Magnetic Resonance Imaging
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Ferric derisomaltose (Drug)
结局指标
主要结局
Ejection Fraction quantified on Cardiac Magnetic Resonance Imaging
时间窗: 24 Hours and 30 days
Changes in Ejection Fraction quoted in (%)
次要结局
- Extracellular Volume (ECV) Fraction quantified on Cardiac Magnetic Resonance Imaging(24 Hours and 30 Days)
- High Sensitivity troponin(24 Hours and 30 Days)
- T1 Mapping 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)
- Ventricular Volumes quantified on Cardiac Magnetic Resonance Imaging(24 Hours and 30 Days)
- Strain analysis as quantified on Cardiac Magnetic Resonance Imaging(24 Hours and 30 Days)
- Haemoglobin(30 Days)
- Quality of Life assessment: KCCQ-12 questionnaire(24 Hours and 30 Days)
- Submaximal Exercise Test: Six Minute Walk Test(24 Hours and 30 Days)
- T2 Mapping quantified on Cardiac Magnetic Resonance Imaging(24 Hours and 30 Days)
- Musculoskeletal function test: Hand grip test(24 Hours and 30 Days)
- Phosphate(24 Hours and 30 Days)
- N-terminal pro B type natriuretic peptide (NTproBNP)(30 Days)